Clinical trial NCT06906575: "Walking Together with Love": a Couples-Based Intervention for Sexual and Relationship Distress in Cancer Patients
Official title: "Walking Together with Love": a Comprehensive Intervention Targeting Body Image, Psychological Flexibility, and Dyadic Coping for Sexual and Relationship Distress Among Cancer Patients and Their Partners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Dysfunction, Psychological
Relationship Distress
Cancer
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer diagnosis and treatment often result in significant changes in body appearance, sexual functioning, and relationship quality, leading to distress for both patients and their partners. To address these challenges, a comprehensive intervention program called "Walking Together with Love" (WTL) has been developed.

This intervention focuses on three key areas: improving body image (supporting patients in accepting physical changes after cancer treatment), enhancing psychological flexibility (enabling patients and partners to openly and positively manage difficult experiences), and strengthening dyadic coping skills (promoting effective communication and emotional support between partners). The primary aim of this intervention is to reduce sexual and relationship distress among cancer patients and their partners.

WTL is a six-week program consisting of weekly 90- to 120-minute sessions delivered in a hybrid format (both online and offline). Sessions incorporate psychoeducational presentations, group discussions, professional guidance, and structured home assignments. Both patients and their partners participate together, collaboratively working toward improving relationship quality and overall well-being.

Cancer patients, their partners, and healthcare providers are encouraged to learn more about this research project and explore its potential benefits in improving quality of life for couples affected by cancer.

Detailed description: Cancer diagnosis and treatment frequently lead to multiple physical, psychological, and interpersonal challenges. Among these, disruptions in body image, sexual functioning, and relationship dynamics are particularly common and distressing for both patients and their intimate partners. Existing evidence suggests that difficulties in accepting body changes, reduced psychological flexibility, and inadequate dyadic coping strategies significantly contribute to sexual and relationship distress among couples facing cancer.

To address these unmet needs, a couples-based intervention called "Walking Together with Love" (WTL) has been developed. Grounded in cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and dyadic coping theory, this intervention integrates three core therapeutic components:

Body Image Improvement:

Supports cancer patients and their partners in understanding and accepting physical changes resulting from cancer treatments.

Fosters positive attitudes toward body image and self-esteem.

Psychological Flexibility Enhancement:

Utilizes ACT-based strategies to improve participants' ability to acknowledge and adaptively manage difficult emotions, thoughts, and experiences related to cancer diagnosis and treatment.

Dyadic Coping Skill Training:

Provides systematic skill-building exercises designed to strengthen mutual support mechanisms, enhance effective communication, and promote collaborative problem-solving when facing cancer-related stressors.

The WTL intervention is delivered in a structured, interactive, and collaborative manner, specifically designed to support both patients and their partners.

Program Duration and Format:

A six-week structured intervention program, with weekly sessions lasting approximately 90-120 minutes.

Sessions are delivered in a hybrid format (virtual and in-person) to maximize accessibility and convenience.

Session Content and Methods:

Each session incorporates psychoeducational presentations, guided discussions, experiential exercises, and structured home assignments.

Core areas covered include managing body image concerns, cultivating psychological flexibility, enhancing intimacy and communication skills, and reinforcing collaborative coping strategies.

Participant Involvement:

Both cancer patients and their intimate partners actively engage in all sessions, participating in therapeutic tasks and home assignments.

This collaborative approach fosters mutual understanding, emotional closeness, and relationship resilience.

Evaluation and Outcome Measures:

To assess the effectiveness of the intervention, multiple time-point assessments will be conducted (pre-intervention baseline, post-intervention, and follow-up assessments).

Outcome measures include sexual and relationship distress, body image acceptance, psychological flexibility, relationship quality, and overall well-being, assessed using validated psychometric instruments.

The primary goal of the WTL intervention is to provide a practical, evidence-based, and scalable approach to alleviating sexual and relationship distress among cancer patients and their intimate partners. By addressing psychological and relational challenges, this intervention aims to enhance quality of life and psychosocial adjustment to cancer.

Eligibility criteria: Inclusion Criteria:

Diagnosed with cancer, with a duration of at least 3 months after surgery; Aged 18-49 and married; were able to complete the questionnaire independently; were willing to participate.

Exclusion Criteria: cognitive or psychiatric impairments and suffering from severe heart, liver, kidney, and other serious complications.

Primary outcomes:
measure: Sexual and Relationship Distress
timeFrame: 3 months after intervention
measure: Relationship Satisfaction
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Body Image
timeFrame: 3 months after intervention
measure: Psychological Flexibility
timeFrame: 3 months after intervention
measure: Dyadic Coping
timeFrame: 3 months after intervention
Other outcomes:
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