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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02721147

Enrollment

Registered

2016-03-29

Start date

2015-10-27

Completion date

2017-09-29

Last updated

2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

BEHAVIORALIntimacy 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.

BEHAVIORALLiving 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.

BEHAVIORALPartner-Assisted Coping Skills Training

Receive couple-based intimacy enhancement intervention

BEHAVIORALBehavioral, Psychological or Informational Intervention

Receive educational information and support

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of the Treatment as Measured Through Study Accrual	Up to 8 weeks	Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
Feasibility of the Treatment as Measured Through Study Attrition	Up to 8 weeks	Feasibility of treatment is measured through the number of randomized participants who completed the study.
Feasibility of the Treatment as Measured Through Session Completion by Participant	Up to 8 weeks	Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)	Up to 8 weeks	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.

Secondary

Measure	Time frame	Description
Change in Beliefs (Self-efficacy)	Baseline to up to 8 weeks	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.
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale	Baseline to up to 8 weeks	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.
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale	Baseline to up to 8 weeks	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.
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item	Baseline to up to 8 weeks	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.
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)	Baseline to up to 8 weeks	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.
Change in Depression Measured Using the Patient Health Questionnaire-9 Item	Baseline to up to 8 weeks	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.
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item	Baseline to up to 8 weeks	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.
Change in Cancer-related Distress Using the Impact of Events Scale-Revised	Baseline to up to 8 weeks	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.
Change in Body Image Distress Measured Using the Body Image Scale	Baseline to up to 8 weeks	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.
Change in Sexual Function Measured Using the International Index of Erectile Function	Baseline to up to 8 weeks	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.
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items	Baseline to up to 8 weeks	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.
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised	Baseline to up to 8 weeks	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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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/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.	40
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.	18
Developmental Substudy 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.	31
Total	89

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	2	0	0

Baseline characteristics

Characteristic	Intimacy Enhancing Intervention	Total	Developmental Substudy	Living Healthy Together
Age, Continuous	54.68 years STANDARD_DEVIATION 10.08	54.92 years STANDARD_DEVIATION 9.73	55.77 years STANDARD_DEVIATION 8.65	53.33 years STANDARD_DEVIATION 10.69
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	4 Participants	2 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants	85 Participants	29 Participants	18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	4 Participants	6 Participants	2 Participants	0 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	2 Participants	0 Participants
Race (NIH/OMB) White	34 Participants	77 Participants	27 Participants	16 Participants
Region of Enrollment United States	40 Participants	89 Participants	31 Participants	18 Participants
Sex: Female, Male Female	20 Participants	61 Participants	31 Participants	10 Participants
Sex: Female, Male Male	20 Participants	28 Participants	0 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 40	0 / 18
other Total, other adverse events	1 / 40	1 / 18
serious Total, serious adverse events	0 / 40	0 / 18

Outcome results

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.

Time frame: 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).

Arm	Measure	Value (MEDIAN)	Dispersion
Participants Eligible For Enrollment	Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)	31.0 score on a scale	Standard Deviation 2.31
Educational Control	Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)	26.5 score on a scale	Standard Deviation 4.68

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.

Time frame: Up to 8 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Participants Eligible For Enrollment	Feasibility of the Treatment as Measured Through Session Completion by Participant	34 Participants
Educational Control	Feasibility of the Treatment as Measured Through Session Completion by Participant	16 Participants

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).

Time frame: Up to 8 weeks

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Participants Eligible For Enrollment	Feasibility of the Treatment as Measured Through Study Accrual	62 Participants

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.

Time frame: Up to 8 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Participants Eligible For Enrollment	Feasibility of the Treatment as Measured Through Study Attrition	38 Participants
Educational Control	Feasibility of the Treatment as Measured Through Study Attrition	18 Participants

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.