Trial Outcomes & Findings for Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer (NCT NCT02721147)

NCT ID: NCT02721147

Last Updated: 2018-10-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 89 participants
• Primary outcome timeframe: Up to 8 weeks
• Results posted on: 2018-10-25

Participant Flow

Participants are randomized only after 1) both partners in the couple complete consent/baseline and 2) the first telephone session is scheduled. Patients who consent without their partner or couples who consent and do not schedule sessions are not randomized.

Participant milestones

Measure	Intimacy Enhancing Intervention Participants attend 4 60-75 minute intimacy enhancement intervention weekly sessions delivered over the telephone to both members of the couple. The intimacy enhancement intervention content covers the following main topics: understanding impact of breast cancer on sex/intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Written handouts are sent to participants included session handouts in advance of the scheduled session. Participants are encouraged to participate in written and behavioral activities at home.	Living Healthy Together Participants attend 4 60-75 minute educational and support weekly sessions delivered over the telephone to both members of the couple. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Written materials are sent to participants in advance of each session. Participants are encouraged to read educational materials and engage in the sessions with the counselor through active discussions.	Developmental Substudy Study-eligible refusers were offered the opportunity to complete a one-time survey assessing reasons for refusal and preferences for obtaining support for sexual concerns. Primary and secondary outcome measures were not collected from these participants.
Overall Study STARTED	40	18	31
Overall Study COMPLETED	38	18	31
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Measure	Intimacy Enhancing Intervention Participants attend 4 60-75 minute intimacy enhancement intervention weekly sessions delivered over the telephone to both members of the couple. The intimacy enhancement intervention content covers the following main topics: understanding impact of breast cancer on sex/intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Written handouts are sent to participants included session handouts in advance of the scheduled session. Participants are encouraged to participate in written and behavioral activities at home.	Living Healthy Together Participants attend 4 60-75 minute educational and support weekly sessions delivered over the telephone to both members of the couple. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Written materials are sent to participants in advance of each session. Participants are encouraged to read educational materials and engage in the sessions with the counselor through active discussions.	Developmental Substudy Study-eligible refusers were offered the opportunity to complete a one-time survey assessing reasons for refusal and preferences for obtaining support for sexual concerns. Primary and secondary outcome measures were not collected from these participants.
Overall Study Lost to Follow-up	2	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intimacy Enhancing Intervention n=40 Participants 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/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 n=18 Participants 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.	Developmental Substudy n=31 Participants Study-eligible patients who refuse participation in the intervention study were asked to complete a one-time survey assessing reasons for refusal and preferences for obtaining support about sexual concerns. Baseline characteristics were collected for this arm. No primary or secondary outcome measures were collected.	Total n=89 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants	85 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants	77 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	40 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants	89 Participants n=4 Participants
Age, Continuous	54.68 years STANDARD_DEVIATION 10.08 • n=5 Participants	53.33 years STANDARD_DEVIATION 10.69 • n=7 Participants	55.77 years STANDARD_DEVIATION 8.65 • n=5 Participants	54.92 years STANDARD_DEVIATION 9.73 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	28 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: 182 eligible individuals were approached for the intervention study and were either classified as study refusers or acceptors.

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

Outcome measures

Measure	Participants Eligible For Enrollment n=182 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control 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.
Feasibility of the Treatment as Measured Through Study Accrual	62 Participants	—

PRIMARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Measure	Participants Eligible For Enrollment n=40 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Feasibility of the Treatment as Measured Through Study Attrition	38 Participants	18 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Measure	Participants Eligible For Enrollment n=40 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Feasibility of the Treatment as Measured Through Session Completion by Participant	34 Participants	16 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: 36/40 participants assigned to the IE condition were analyzed (2 participants did not complete sessions and were not given any measures assessing satisfaction with the sessions; 2 participants did not return the post-intervention survey).

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=36 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)	31.0 score on a scale Standard Deviation 2.31	26.5 score on a scale Standard Deviation 4.68

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This outcome is female-specific and was only measured in patients. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=19 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=9 Participants 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.
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)	9.76 score on a scale Interval 5.67 to 13.84	-0.38 score on a scale Interval -6.27 to 5.51

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This measure was administered to male partners. 7/9 partners in the educational control arm were analyzed because 1 partner was female and 1 partner had incomplete data at follow-up. 19/20 partners in the IE condition were analyzed because 1 partner did not complete follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=19 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=7 Participants 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.
Change in Sexual Function Measured Using the International Index of Erectile Function	5.26 score on a scale Interval -1.3 to 11.83	-2.57 score on a scale Interval -6.15 to 1.0

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to both patients and partners. 38/40 IE participants analyzed because 2 participants were lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=38 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items	5.63 score on a scale Interval 3.15 to 8.1	-0.86 score on a scale Interval -3.13 to 1.42

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=19 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=9 Participants 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.
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised	-9.21 score on a scale Interval -13.86 to -4.56	-1.44 score on a scale Interval -7.69 to 4.8

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to both patients and partners. 38/40 IE participants analyzed because 2 participants were lost to follow-up. 17/18 Educational Control participants were analyzed because 1 participant did not complete the scale at follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=38 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=17 Participants 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.
Change in Beliefs (Self-efficacy)	18.51 score on a scale Interval 10.48 to 26.53	1.37 score on a scale Interval -5.87 to 8.62

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=38 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale	0.08 score on a scale Interval -0.12 to 0.29	0.20 score on a scale Interval -0.1 to 0.51

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=38 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale	6.77 score on a scale Interval 3.19 to 10.36	1.50 score on a scale Interval -3.39 to 6.69

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=38 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item	0.71 score on a scale Interval -0.29 to 1.71	1.28 score on a scale Interval -1.55 to 4.11

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=19 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=9 Participants 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.
Change in Body Image Distress Measured Using the Body Image Scale	-2.63 score on a scale Interval -4.47 to -0.79	-1.78 score on a scale Interval -6.0 to 2.45

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=19 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=9 Participants 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.
Change in Depression Measured Using the Patient Health Questionnaire-9 Item	-1.95 score on a scale Interval -3.5 to -0.39	0.00 score on a scale Interval -2.03 to 2.03

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=19 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=9 Participants 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.
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item	-1.74 score on a scale Interval -3.1 to -0.38	3.11 score on a scale Interval 0.25 to 5.97

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.

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.

Outcome measures

Measure	Participants Eligible For Enrollment n=38 Participants Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.	Educational Control n=18 Participants 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.
Change in Cancer-related Distress Using the Impact of Events Scale-Revised	-3.55 score on a scale Interval -7.41 to 0.31	-0.94 score on a scale Interval -6.98 to 5.09

Adverse Events

Intimacy Enhancing Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Educational Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intimacy Enhancing Intervention n=40 participants at risk 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/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.	Educational Control n=18 participants at risk 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.
Psychiatric disorders Suicidal Ideation	2.5% 1/40 • Number of events 2 • Participants were monitored for adverse events at the two survey time points (baseline, 8 weeks) and over the course of the telephone sessions. A participant was considered to have an adverse event if 1) they reported suicidal ideation on their survey (item #9 on the Patient Health Questionnaire-9, which assesses thoughts about self-harm) or 2) if they indicated extreme distress or thoughts of self-harm/suicidal ideation to their counselor during the telephone sessions.	5.6% 1/18 • Number of events 1 • Participants were monitored for adverse events at the two survey time points (baseline, 8 weeks) and over the course of the telephone sessions. A participant was considered to have an adverse event if 1) they reported suicidal ideation on their survey (item #9 on the Patient Health Questionnaire-9, which assesses thoughts about self-harm) or 2) if they indicated extreme distress or thoughts of self-harm/suicidal ideation to their counselor during the telephone sessions.

Additional Information

Dr. Jennifer Reese, Assistant Professor

Fox Chase Cancer Center

Phone: 215-214-3223

Email: Jennifer.Reese@fccc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place