Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

NCT02721147 | Completed Results

• 2 other identifiers: 15-80071R21CA191354-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Feasibility of the Treatment as Measured Through Study Accrual

  Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).

  Up to 8 weeks

• Feasibility of the Treatment as Measured Through Study Attrition

  Feasibility of treatment is measured through the number of randomized participants who completed the study.

  Up to 8 weeks

• Feasibility of the Treatment as Measured Through Session Completion by Participant

  Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.

  Up to 8 weeks

• Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)

  Acceptability was measured through the median score on a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate higher satisfaction with the service (acceptability). A median score of 28 or higher is considered acceptable. This measure was collected for both patients and partners.

  Up to 8 weeks

Secondary Outcomes (12)

• Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)

  Baseline to up to 8 weeks

• Change in Sexual Function Measured Using the International Index of Erectile Function

  Baseline to up to 8 weeks

• Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items

  Baseline to up to 8 weeks

• Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised

  Baseline to up to 8 weeks

• Change in Beliefs (Self-efficacy)

  Baseline to up to 8 weeks

Study Arms (2)

Intimacy Enhancing Intervention

EXPERIMENTAL

Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.

Behavioral: Intimacy Enhancing Intervention; Behavioral: Partner-Assisted Coping Skills Training

Living Healthy Together

ACTIVE COMPARATOR

Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.

Behavioral: Living Healthy Together; Behavioral: Behavioral, Psychological or Informational Intervention

Interventions

Intimacy Enhancing Intervention BEHAVIORAL

Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.

Intimacy Enhancing Intervention

Living Healthy Together BEHAVIORAL

Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.

Living Healthy Together

Partner-Assisted Coping Skills Training BEHAVIORAL

Receive couple-based intimacy enhancement intervention

Intimacy Enhancing Intervention

Behavioral, Psychological or Informational Intervention BEHAVIORAL

Receive educational information and support

Living Healthy Together

Eligibility Criteria

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

You may qualify if:

• Female
• Age \> 21 years
• Has diagnosis of non-recurrent stage I-III breast cancer
• Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
• Has a partner or spouse who is \> 21
• Lives with a romantic partner \> 6 months
• Score of \> 3 on Patient Care Monitor Sexual Concerns screening item
• No hearing impairment in patient or partner

You may not qualify if:

• Not able to speak English, as stated in medical record or as observed by study team member
• ECOG Performance score \> 2 OR too ill to participate as judged by physician/in medical record
• Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
• Past history of any cancer other than non-melanoma skin cancer
• Currently participating in couple/marital therapy
• Currently pregnant

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jennifer Reese, Assistant Professor
• Organization: Fox Chase Cancer Center

Jennifer.Reese@fccc.edu

215-214-3223

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 29, 2016
• Study Start: October 27, 2015
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: October 25, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-10

Locations

US (1)