Sexual Dysfunction, PsychologicalWTLNCT06906575
"Walking Together with Love": a Couples-Based Intervention for Sexual and Relationship Distress in Cancer Patients
A study testing A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners in people with Sexual Dysfunction, Psychological and Relationship Distress, run by Yanfei Jin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Sexual Dysfunction, Psychological, Relationship Distress, Cancer
- What is being tested?
- A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 26 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners
- Medical subject headings
- Sexual Dysfunctions, Psychological, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their PartnersBehavioural
This intervention targets three core areas:
Body Image Improvement - Supports patients in understanding and accepting physical changes resulting from cancer treatments, fostering positive attitudes toward body image and self-esteem.
Psychological Flexibility Enhancement - Utilizes ACT-based strategies to help participants acknowledge and adaptively manage difficult emotions, thoughts, and experiences related to cancer diagnosis and treatment.
Dyadic Coping Skill Training - Provides structured skill-building exercises to strengthen mutual support mechanisms, enhance effective partner communication, and promote collaborative problem-solving when facing cancer-related stressors.
The intervention consists of six weekly sessions (90-120 minutes each), delivered in a hybrid format (virtual and in-person) to maximize accessibility. Each session integrates psychoeducational presentations, facilitated discussions, guided experiential exercises.
| Study group | Role | What they receive |
|---|---|---|
| Walking Together with Love | Experimental | Not described Receives: Behavioral: A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual and Relationship Distress
The Sexual and Relationship Distress Scale (SaRDS) is used to measured the Sexual and Relationship Distress .The SaRDS is a 30-item, 14-factor patient-reported outcome measure of individual and relationship distress within the context of sexual dysfunction14. All items are rated on a 7-point Likert scale ("not at all true" to "completely true"). The total scores range from 0 to 180 and reflect the standard of individual and relationship distress within the context of sexual dysfunction, with high values indicating more distress. In the original version of the study, the SaRDS showed good psychometric properties, and the subsequent studies also reported the strong internal consistency of the SaRDS (Cronbach alpha = .95 for the total score with individual sub-scales ranging from .70-.96).
Measured: 3 months after intervention
Relationship Satisfaction
The Couples Satisfaction Index (CSI-16) is a validated measure of relationship satisfaction, assessing perceived intimacy, emotional closeness, and overall satisfaction within the relationship. Higher scores indicate greater relationship satisfaction.
Measured: 3 months after intervention
Secondary outcomes (3)
Body Image
The Body Image Scale (BIS) will be used to assess body image concerns among cancer patients. The BIS is a validated 10-item self-report questionnaire designed to evaluate body image distress, self-consciousness, and changes in body perception following cancer treatment. Higher scores indicate greater body image disturbance.
Measured: 3 months after intervention
Psychological Flexibility
Measurement Tool: The Acceptance and Action Questionnaire-II (AAQ-II) will be used to assess psychological flexibility. The AAQ-II is a validated 7-item self-report measure that evaluates experiential avoidance and the ability to accept thoughts and emotions while engaging in values-based actions. Higher scores indicate greater psychological inflexibility, while lower scores reflect higher psychological flexibility.
Measured: 3 months after intervention
Dyadic Coping
Measurement Tool: The Dyadic Coping Inventory (DCI) will be used to assess dyadic coping strategies among cancer patients and their partners. The DCI is a validated self-report questionnaire that evaluates how partners support each other in managing stress, communicate emotions, and engage in joint coping efforts. Higher scores indicate more effective dyadic coping and greater relationship resilience.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion26 Oct 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunction, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanfei Jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanfei Jin, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906575
- Sponsor's protocol ID
- 2024-749
- Other IDs
- 2024-749
- Acronym
- WTL
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06906575
- Acronym / sponsor ID
- WTL / 2024-749
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yanfei JinUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 26 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking Together with Love | Experimental | Behavioral: A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their PartnersThis intervention targets three core areas: Body Image Improvement - Supports patients in understanding and accepting physical changes resulting from cancer treatments, fostering positive attitudes toward body image and self-esteem. Psychological Flexibility Enhancement - Utilizes ACT-based strategies to help participants acknowledge and adaptively manage difficult emotions, thoughts, and experiences related to cancer diagnosis and treatment. Dyadic Coping Skill Training - Provides structured skill-building exercises to strengthen mutual support mechanisms, enhance effective partner communication, and promote collaborative problem-solving when facing cancer-related stressors. The intervention consists of six weekly sessions (90-120 minutes each), delivered in a hybrid format (virtual and in-person) to maximize accessibility. Each session integrates psychoeducational presentations, facilitated discussions, guided experiential exercises. | Behavioural | Walking Together with Love |
Primary outcome
Sexual and Relationship Distress
Time frame: 3 months after intervention
The Sexual and Relationship Distress Scale (SaRDS) is used to measured the Sexual and Relationship Distress .The SaRDS is a 30-item, 14-factor patient-reported outcome measure of individual and relationship distress within the context of sexual dysfunction14. All items are rated on a 7-point Likert scale ("not at all true" to "completely true"). The total scores range from 0 to 180 and reflect the standard of individual and relationship distress within the context of sexual dysfunction, with high values indicating more distress. In the original version of the study, the SaRDS showed good psychometric properties, and the subsequent studies also reported the strong internal consistency of the SaRDS (Cronbach alpha = .95 for the total score with individual sub-scales ranging from .70-.96).
Relationship Satisfaction
Time frame: 3 months after intervention
The Couples Satisfaction Index (CSI-16) is a validated measure of relationship satisfaction, assessing perceived intimacy, emotional closeness, and overall satisfaction within the relationship. Higher scores indicate greater relationship satisfaction.
3 secondary outcomes
Body Image
Time frame: 3 months after intervention
Psychological Flexibility
Time frame: 3 months after intervention
Dyadic Coping
Time frame: 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners in people with Sexual Dysfunction, Psychological and Relationship Distress, run by Yanfei Jin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanfei Jin (16672040891, alisaflower@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual and Relationship Distress (time frame: 3 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.