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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
89
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.
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.
Receive couple-based intimacy enhancement intervention
Receive educational information and support
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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.
Time frame: Baseline to up to 8 weeks
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