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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721147
• Other study ID #: 15-8007
• Secondary ID: 1R21CA191354-01
• Status: Completed
• Phase: N/A
• Start date: October 27, 2015
• Est. completion date: September 29, 2017

Study information

• Verified date: October 2018
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Female

2. Age > 21 years

3. Has diagnosis of non-recurrent stage I-III breast cancer

4. Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)

5. Has a partner or spouse who is > 21

6. Lives with a romantic partner > 6 months

7. Score of > 3 on Patient Care Monitor Sexual Concerns screening item

8. No hearing impairment in patient or partner

Exclusion Criteria:

1. Not able to speak English, as stated in medical record or as observed by study team member

2. ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record

3. 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.

4. Past history of any cancer other than non-melanoma skin cancer

5. Currently participating in couple/marital therapy

6. Currently pregnant

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Intimacy Enhancing Intervention
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.
• Living Healthy Together
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.
• Partner-Assisted Coping Skills Training
Receive couple-based intimacy enhancement intervention
• Behavioral, Psychological or Informational Intervention
Receive educational information and support

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)	Total scale scores range from 2 to 36. Higher scores indicate higher level of functioning. Change in mean patient FSFI score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Sexual Function Measured Using the International Index of Erectile Function	Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items	The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10. Higher T-scores indicate higher levels of sexual satisfaction. Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported. Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised	Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Beliefs (Self-efficacy)	Total scale scores range from 0 to 100. Higher scores indicate higher degree of self-efficacy for coping with sexual concerns. Change in mean self-efficacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale	Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner. Change in mean emotional intimacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale	Total scale scores range from 13 to 78. Higher scores indicate more communication. Change in mean sexual communication score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item	Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Body Image Distress Measured Using the Body Image Scale	Total scale scores range from 0 to 30. Higher scores indicate higher level of body image distress. Change in mean body image distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Depression Measured Using the Patient Health Questionnaire-9 Item	Total scale scores range from 0 to 27. Higher scores indicate higher level of depression. Change in mean depression score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in depression from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item	Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.	Baseline to up to 8 weeks
Secondary	Change in Cancer-related Distress Using the Impact of Events Scale-Revised	Total scale scores range from 0 to 88. Higher scores indicate higher levels of distress. Change in mean cancer-related distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in distress from pre- to post-intervention.	Baseline to up to 8 weeks