Table 1 Characteristics of excluded trials
Author (s) Location/(year) | Study design | Study groups | Type of intervention/s | Type of blinding | Follow-up period | Number of participants in each group | Health status of participants | Main outcome/s | Secondary outcome/s | Results | Theoretical frameworks/theories |
|---|---|---|---|---|---|---|---|---|---|---|---|
Baucom et al. USA/(2009) [36] | Pilot RCT | Group 1: Intervention group Group 2: Control group | Intervention group: Couple-based relationship enhancement (RE) Face-to-face Frequency: 1/2weeks Duration: 12 weeks six sessions of 75 min Delivery with a psychologist Control group: Treatment-as-usual (TAU) | Double-blind | Post-treatment, and 12 months later. | Intervention group: 8 Control group: 6 | Women with stage I-II breast cancer, no history of other breast cancer, and no history of cancer within the last 5 years | Patients: Relationship functioning (relationship satisfaction and sexual functioning), psychological functioning (brief symptom, posttraumatic growth, functional assessment of cancer therapy, self-image), cancer-related medical symptoms (brief fatigue, brief pain, Rotterdam symptom) partners: Relationship functioning (relationship satisfaction and sexual functioning), psychological functioning (brief symptom, posttraumatic growth) | At both posttest and 1-year follow-up, couples who participated in relationship education (RE) showed greater improvements in individual psychological and relationship functioning, as well as relationship satisfaction, compared to those who did not receive RE (TAU). Additionally, women who participated in RE reported experiencing fewer medical symptoms than women in the TAU group. | Non-Clear | |
Budin et al. New York /(2008) [37] | RCTa | Group 1: Intervention group Group 2: Intervention group Group 3: Intervention group Group 4: Control group | Intervention group: 1) Standardized psychoeducation (SE): Four phase-specific psychoeducation videos (coping, recovering from surgery, understanding adjuvant therapy, and recovery) 2) Telephone counseling (TC): Enhance the patient’s and partner’s sense of control and mastery 3) Standardized psychoeducation plus telephone counseling (SE + TC): Four sessions delivery with trained nurses Control group: Standard care (disease management: DM) | Open-label design | Post-surgery, Adjuvant therapy, and Ongoing recovery phases ( 2 weeks after completion of chemotherapy or radiation or 6 months after surgery if no adjuvant therapy was received) | Intervention group for the patient: SE: 45 TC: 42 (SE + TC): 40 Control group for the patient: DM: 50 Intervention group for partners: SE: 34 TC: 30 (SE + TC): 29 Control group for partners: DM: 33 | The patients who were diagnosed with a confirmed or strongly suspected breast cancer lesion, and their partners. | Emotional adjustment: Psychological well-being Physical adjustment: Overall health status, physical symptoms Social adjustment: Vocational, domestic, and social environments | The findings of the study showed that the intervention had no statistically significant for patients in groups about psychological well-being (p = 0.62), overall health (p = 0.82), vocational environment (p = 0.052), or social environment (p = 0.92). The intervention had a significant difference in the physical symptoms (p = 0.024) and vocational environment (p = 0.046) of partners. | The theoretical framework was based on the stress and coping model of Lazarus and Folkman, and the crisis intervention model. | |
Christensen. USA/ (1983) [42] | RCTa | Group 1: Treatment group Group 2: Control group | Intervention group: Counseling for couples after a mastectomy Face to face 4 sessions Duration: 6 weeks Frequency: 1/week Delivery with trained counselors Control group: Not Clear | Open-label design | One week post-intervention | Intervention group: 10 Control group: 10 | Patients with non-metastatic breast cancer who had undergone surgery at least 2 months before the experiment but no more than 3 months prior and also their partners. | Patients: Psychological screening (emotional discomfort), marital adjustment, sexual satisfaction, depression, self-esteem, internal-external locus of control Partners: Psychological screening (emotional discomfort), marital adjustment, sexual satisfaction, depression, self-esteem, internal-external locus of control | The treatment increased sexual satisfaction and decreased emotional discomfort for dyads (p < 0.05), and decreased depression in patients (p < 0.05). The Intervention did not significantly affect marital adjustment between the treatment group’s mean score of 106.15 ± 20.68 and the control group’s mean score of 99.6 ± 17.88. | Non-Clear | |
Comez and Karayurt. Turkey/(2020) [25] | Quasi-experimental ( pretest-posttest with control group) | Group 1: Intervention group Group 2: Control group | Intervention group: Web-based training (breast cancer and treatment methods, the prevention and management of the symptoms that are related to the treatment, arm-shoulder exercises, sexuality, pregnancy write questions and receive answers) Website Frequency: Available during intervention Duration: 3 months Delivery with research nurses Control group: Routine nursing care | Open-label design | Three months post-intervention | Intervention group: 41 Control group: 42 | Primary stage I or stage II breast cancer diagnosis, having mastectomy or breast-conserving surgery in the last 10 days | Patients: -Functional assessment of cancer therapy-breast (FACT-B): Life quality -Dyadic adjustment (DAS) Partners: -Dyadic adjustment (DAS) | The finding of the study showed that there were significant positive differences in dyadic adjustment among women and their partners in the intervention and control group in the third month after the web-based training (p < 0.001). There were significant differences in the life quality of women in the Intervention Group compared with the control group after the web-based training (p < 0.05). | The conceptual framework of the present study consisted of the Roy Adaptation Model (RAM). | |
Fergus et al. Canada/(2022) [19] | Multicenter RCT | Group 1: Treatment group Group 2: Control group | Treatment group: Couple links online intervention with website 6 sessions Duration: 8 weeks Frequency: 1/week Delivery with trained facilitators (five mental health professionals) Control group: Waitlist control (Did not receive any intervention) | Open-label design | Post-intervention, Follow-up: Three months after intervention | Treatment group: 31 Control group: 36 | Non-metastatic, invasive breast cancer or ductal carcinoma in situ within the last 36- month | Patients: Dyadic coping, dyadic adjustment, marital satisfaction, breast cancer, and relationship Partners: Dyadic coping, dyadic adjustment, marital satisfaction, breast cancer, and relationship | Patients: Depression and anxiety Partners: Depression and anxiety | The treatment group showed a significant improvement in positive dyadic coping (p = 0.032), breast cancer, and relationship (p = 0.04), but positive effects were not sustained at the 3-month follow-up The treatment group showed a significant decrease in their anxiety levels over time (p = 0.03). The study did not observe any impact on the overall relationship adjustment. | Non-Clear |
Hedayati et al. Iran/(2020) [41] | pretest-posttest control group design | Group 1: Intervention group Group 2: Control group | Intervention group: Emotionally focused couple therapy (EFT) 6 sessions (120 min per session) Face to face Duration: 6 weeks Frequency: 1/week Control group: Did not receive any intervention | Open-label design | Post Intervention | Intervention group: 11 Control group: 11 | Breast Cancer with stage II, post-mastectomy | Couples: Marital intimacy | The statistical analysis showed a significant difference in the components of marital intimacy from the pre-test to the post-test (p < 0.01). The intervention group exhibited higher mean scores for every component of marital intimacy following their participation in the educational program, as compared to the control group. | Emotionally focused couples therapy taken from the suggestions of Susan Johnson known as HMT (Hold Me Tight) | |
Jonsdottir (2021) Iceland [17] | quasi-experimental(one-group pre and post setup) | Group 1: Intervention group Group 2: Control group | Intervention group: Couple strengths-oriented therapeutic conservations (CO-SOTC) + web-based evidence-based educational information Three sessions of 45 min Face to face Frequency: 1–2 weeks apart and the final session was conducted 3 months after the first session Duration: 3 months Delivery with nurses Control group: Wait-list (Did not receive any intervention) | Open-label design | Two weeks post-intervention and assessment over three months | Intervention group = 34 Control group: 26 | 60 couples diagnosed with cancer (regardless of type and stage), currently in active cancer treatment | -Ice-beliefs: Illness beliefs about sexuality and intimacy -Relationship quality -Dyadic difference | ------ | The CO-SOTC intervention had significant differences in sexuality, intimacy (p < 0.001), and overall quality of the relationship (P = 0.005) of both women and their partners over time. | The theoretical model of the study is a family strength-oriented therapeutic conversation (FAM-SOTC). |
Kalaitz et al. Greece/(2007) [43] | RCTa | Group 1: Intervention group Group 2: Control group | Intervention group: a combination of brief couples and sex therapy (CBPI) Face to face 6 sessions Frequency:1/2 weeks Duration: 3 months Delivery with trained therapists Control group: Not clear | Open-label design | Post Intervention | Intervention group: 20 Control group: 20 | Underwent simple mastectomy for in situ, primary breast cancer; negative for estrogens/ progesterone receptors; no patient received tamoxifen, chemotherapy, or radiation therapy | Patients: Anxiety, depression, sexuality and body image (satisfaction with relationship and satisfaction with body image) | The patients who received the combined brief psychosexual intervention (CBPI) exhibited noteworthy improvements in various aspects of their well-being. Specifically, they showed significant improvement in depression (p = 0.013) and state anxiety (p = 0.006), as well as in body image, satisfaction with their relationship (p < 0.001), presumed attractiveness to their partner, frequency of orgasms (p = 0.042), and communication about their desires. | Non-Clear | |
Li et al. China/ (2023) [6] | RCTa | Group 1: Intervention group Group 2: Control group | Intervention group: WeChat couple-based psychosocial support (articles about psychoeducation, skills training, and counseling) Session: Not Clear Frequency: 1/2days Duration: 8 weeks Control group: Received six WeChat articles on general education content related to diet and exercise | Open-label design | Post-intervention and three months after the intervention. | Intervention group: 49 Control group: 49 | women with a newly diagnosed gynecological cancer (ovarian, uterine, cervical, vulvar, and vaginal cancer) 6 weeks after any surgery | Patients: Sexual function | Patients and partners: Dyadic adjustment and quality of life | It was found that the dyadic adjustment was improved significantly in the intervention program in women (p = 0.001) and their partners (p = 0.027). The intervention program also demonstrated statistically significant positive effects on the quality of life of women with gynecological cancer (p = 0.035). | Systemic Transactional Model of Stress and Coping and effective couple-based intervention approaches. |
Nho et. South Korea /(2019) [38] | Quasi-experimental (pretest-posttest design) | Group 1: Intervention group Group 2: Control group | Intervention group: Web-based sexual health enhancement program (WSHEP) (five modules and each module consisted of between one and six interventions) Five sessions Frequency: Not clear Duration: Four week Delivery with nurses Control group: underwent the current standard of care routinely provided in the clinic | Open-label design | After 4 months | Intervention group: 21 couples Control group: 22 couples | -Women with Stage I-II gynecological cancer -Completed cancer treatment -No contraindication for sexual intercourse | Patients: Sexual function, sexual distress, and marital intimacy Partners: Marital intimacy | ------ | WSHEP had a significant improvement in all dimensions of sexual function (p < 0.001) of women and in the marital intimacy of husbands (p = 0.015) | The framework was designed using intervention strategies based on the PLISSIT model. |
Nicolaisen et al. Denmark/ (2018) [39] | Multicenter RCT | Group 1: Intervention group Group 2: Control group | Intervention group: Hand-in-hand (HiH) intervention + usual care (enhance dyadic adjustment through dyadic coping within the couples) Face to face 4–8 sessions Frequency: Not clear Duration: up to 5 months after primary surgery Delivery with clinical psychologists Control group: Usual care (verbal and written information on normal psychological reactions about a cancer diagnosis) | Single blind | Post-intervention (five months after surgery), follow-up (10 months after surgery) | Intervention group: 82 Control group: 64 | newly diagnosed with primary breast cancer had received no neo-- adjuvant treatment | Patients’ cancer-related distress | Cancer-related distress, symptoms of anxiety and depression, dyadic adjustment | HiH intervention did not significantly affect Cancer-related distress at post-intervention (p = 0.08 or follow-up (p = 0.71). There was a positive significant difference in the level of dyadic adjustment at follow-up for both patients (p = 0.04) and partners (p = 0.02). | The theoretical framework attachment theory explains how attachment behavior and attachment style may influence the exchange of support within couples and their adjustment to BC. |
Price-Blackshear et al. USA/(2020) [24] | RCTa | Group 1: Intervention group Group 2: Control group | Intervention group: CMBI (couples mindfulness-based intervention) 8 sessions of one-hour prerecorded videos Frequency: 1/week Duration: 8 weeks Delivery with trained MBSR teachers Control group: I-MBI (Individual mindfulness-based intervention) | Open-label design | Post Intervention | Intervention group: 36 Control group: 41 | One-year post-diagnosis; within 6 years of diagnosis; breast cancer stages 0- III | Perceived stress, depression, and anxiety, The mindful attention and awareness | Dyadic adjustment, relationship satisfaction, interpersonal mindfulness | Levels of perceived stress and anxiety were lower after the intervention in both C-MBI and I-MBI groups (p < 0.001). The dyadic adjustment was lower for patients (Baseline Mean = 98.54, Post-intervention Mean 95.50) and relatively no change for partners (Baseline Mean = 100.78, Post-intervention Mean = 101.71) in the C-MBI condition. Relationship satisfaction was lower for patients (Baseline mean = 35.26, Post-intervention Mean = 34.12) and their partners (Baseline Mean = 37.04, Post-intervention Mean = 35.67) in the C-MBI condition. | Non-Clear |
Reese et al. USA/(2018) [40] | Pilot RCT | Group 1: Intervention group Group 2: Control group | Intervention group: Couple-based intervention, Intimacy enhancement (IE) (evidence-based sexuality interventions) via Telephone 4 sessions of 60–75 min Frequency: 1/week Duration: 4 weeks Delivery with trained psychosocial providers Control group: Usual care 4 session | Open-label design | Post-intervention | Intervention group: 19 Control group: 9 | Had completed active treatment 6 months − 5 years ago for non-recurrent Stage I–III breast cancer (current use of endocrine therapy was acceptable | Patients and partners: -Sexual outcomes: Sexual function, sexual satisfaction, sexual distress, and self-efficacy -Relationship outcomes: Dyadic sexual communication, emotional intimacy, dyadic adjustment, -Psychosocial outcomes: cancer-related distress, body image distress, depressive symptoms and anxiety | The intervention had a large effect on sexual satisfaction (Effect size 1.75) in women and a medium effect among their partners (Effect size 0.52). Regarding relationship outcomes, there was no change in emotional intimacy (Effect size = 0.04) among women and a small effect on their partners (Effect size= -0.44). Also in psychosocial outcomes, there was a large effect for a reduction in anxiety symptoms (Effect size= -1.36) among women. | Theories of behavioral Couples. | |
Zhang et al. China/(2022) [23] | RCTa | Group 1: Intervention group Group 2: Control group | Intervention group: Nurse-led couple intervention + routine nursing care (recognizing and facing up to family and marital problems, enhancing communication skills, and learning to solve intimate relationship issues) Four sessions of one hour Frequency: 1/month Duration: 4 months Delivery with trained nurses Control group: Routine nursing care | Single-blind | Two months post-intervention and three months post-intervention | Intervention group: 46 Control group: 49 | Confirmed diagnosis of gynecological cancer (ovarian tumor, endometrial carcinoma, and cervical cancer) at I-IV FIGO stage, undergoing surgery and/or periodic radiotherapy and/or chemotherapy | Patients and partners: Marital quality: Marital satisfaction, marital communication, and sexual life | The intervention group consisting of patients and their husbands reported significantly improved scores in marital satisfaction (P = 0.028). The intervention did not have a significant impact on patient-reported or husband-reported sexual life (P = 0.073). | The Preliminary Live with Love Conceptual Framework (P-LLCF). |