Marital Satisfaction and Sexual Health of Female Cancer Patients in Singapore

NCT03420547 | Completed DMC

• 1 other identifier: Duke-NUS
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Disturbances in marital intimacy and sexual health is one of the most underrated and undertreated problems in cancer survivorship. A review on unmet supportive care needs of cancer patients noted one third to more than half of patients reported support for sexual disturbances as an area of unmet need during and after treatment. Patients, whose sense of femininity and body image may be at risk, such as in the case of breast and gynaecologic cancers, may be more susceptible to such intimacy and sexual disturbances. According to a recent study conducted in Singapore, 25% of gynaecologic cancer patients reported dissatisfaction with their bodies and 19% reported feeling less sexually attractive. Unfortunately, there is paucity in formal resources for couples counselling within the oncology setting in Singapore. The current study seeks to investigate a pilot program called Renewing Intimacy and Sexuality (RISE), which consists of 3 sessions with female cancer patients and their spouses, and that combine components of psychosexual education, communication training and skills building. The reach, acceptability, implementation, and preliminary effectiveness of the RISE program will be assessed based on the RE-AIM framework for program planning. The overall aim of the research project is to establish evidence-based programs for cancer survivors to enhance their quality of life.

Conditions

Gynecologic Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Assess the reach of the RISE program

  Measured by proportion of those who enrol to those who are eligible to participate.

  Baseline

• Determine the acceptability of the RISE program

  Measured by participant rated satisfaction with the program using the Client Satisfaction Questionnaire

  Week 6 for intervention arm; Week 12 for waitlist arm

• Success of implementation of the program.

  Measured by participant's willingness to pay for the program.

  Week 6 for intervention arm; Week 12 for waitlist arm

• Collect feedback to improve the RISE program

  Obtained by conducting semi-structured interviews with participants at program completion.

  Week 6 for intervention arm; Week 12 for waitlist arm

Secondary Outcomes (1)

• Preliminary data on effectiveness of the program.

  Change in scores from Baseline to Week 6 for intervention arm; change in scores from Baseline to Week 12 for Waitlist arm

Study Arms (2)

Intervention group

EXPERIMENTAL

Group of participants receiving the RISE intervention

Behavioral: RISE

Standard Care (waitlist)

NO INTERVENTION

Group receiving no intervention in first 6 weeks.They will have the option of participating in the RISE program after their second assessment at week 6.

Interventions

RISE BEHAVIORAL

Intervention will consist of 3 sessions over 6 weeks. Each session will last 2 hours and be conducted with a clinical psychologist or medical social worker. The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.

Intervention group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 years or old
• Has a spouse/ romantic partner
• History of stage I-III gynaecologic or breast cancer
• At least 4 weeks post completion of active treatment (i.e., surgery, chemotherapy, radiation therapy)
• Patient meets cut-off for marital distress on the Dyadic Adjustment Scale-4 (defined as overall score of ≤ 12) or sexual distress (defined as endorsing "occasionally" - "always" to the question how often patient felt distress about their sex life in the last 30 days)
• Speak and read English

You may not qualify if:

• Diagnosis of metastatic (stage IV) cancer
• Visual, hearing, or cognitive impairment that will interfere with participation

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead

Study Sites (2)

KK Women's and Children's Hospital

Singapore, Singapore, Singapore

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Related Publications (3)

• Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001 Aug;44(2):119-27. doi: 10.1016/s0738-3991(00)00186-5.

  PMID: 11479052 BACKGROUND

• Teo I, Cheung YB, Lim TYK, Namuduri RP, Long V, Tewani K. The relationship between symptom prevalence, body image, and quality of life in Asian gynecologic cancer patients. Psychooncology. 2018 Jan;27(1):69-74. doi: 10.1002/pon.4457. Epub 2017 Jun 16.

  PMID: 28508411 BACKGROUND

• Teo I, Tan YP, Goh A, Pan FT, Tan TJ, Ozdemir S, Cheung YB, Chaudhry I, Razali NS, Tewani KG. The Renewing Intimacy and SExuality Intervention for Female Cancer Survivors: A Feasibility Study. Psychooncology. 2024 Dec;33(12):e70037. doi: 10.1002/pon.70037.

  PMID: 39638564 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Irene Teo, PhD

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 5, 2018
• Study Start: November 1, 2018
• Primary Completion: July 31, 2022
• Study Completion: January 1, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)