Coping Together After Breast Cancer

Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03930797

Enrollment

240

Registered

2019-04-29

Start date

2019-05-24

Completion date

2023-04-14

Last updated

2024-07-11

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 objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes.

Detailed description

Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE). The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups.

Interventions

BEHAVIORALIntimacy Enhancement

The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.

BEHAVIORALLiving Healthy Together

The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is female * Patient age 18 years or older * Patient has a medically confirmed diagnosis of non-recurrent breast cancer (Stages T1-T4, N0-N1, M0) * Patient completed active treatment (e.g., chemotherapy, radiation therapy, surgery, immunotherapy) 6 months-5 years ago (current use of endocrine therapy is acceptable) * Patient is currently in a partnered relationship that could involve sexual activity * Partner or spouse is 18 years or older * Patient lives with a romantic partner for at least 6 months * Patient has a score of at least 3 on Patient Care Monitor Sexual Concerns screening item

Exclusion criteria

* Patient or partner is not able to speak and read English, as stated in medical record, as observed by study team member or in self-report * Patient or partner ECOG Performance score \> 2 OR medically unable to participate as judged by physician/in medical record or by self-report * Patient or partner has a hearing impairment * Patient and partner do not have reliable telephone access * Patient has overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, physician or referring source, or self-report * Patient past or current history of any cancer other than non-melanoma skin cancer, including prior breast cancer * Patient is currently participating in couple/marital therapy * Patient is currently pregnant

Design outcomes

Primary

Measure	Time frame	Description
Change in Self-Reported Patient Sexual Function	Baseline up to 6 weeks	Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.

Secondary

Measure	Time frame	Description
Change in Self-Reported Patient Sexual Distress	Baseline up to 6 weeks	Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress.
Change in Patients' Self-Reported Relationship Intimacy	Baseline up to 6 weeks	Patient self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Change in Partners' Self-Reported Relationship Intimacy	Baseline up to 6 weeks	Partner self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Change in Patients' Self-Reported Relationship Quality	Baseline up to 6 weeks	Patient self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Change in Self-Reported Partner Sexual Function	Baseline up to 6 weeks	Partners' (male) self-reported sexual function will be measured using the 15-item International Index of Erectile Function (IIEF). 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 over time will be reported. Positive mean change scores indicate increase in sexual functioning.
Change in Patients' Self-Reported Anxiety	Baseline up to 6 weeks	Patients' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.
Change in Partners' Self-Reported Anxiety	Baseline up to 6 weeks	Partners' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.
Change in Patients' Self-Reported Depressive Symptoms	Baseline up to 6 weeks	Patients' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.
Change in Partners' Self-Reported Depressive Symptoms	Baseline up to 6 weeks	Partners' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.
Change in Partners' Self-Reported Relationship Quality	Baseline up to 6 weeks	Partner self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.

Countries

United States

Participant flow

Pre-assignment details

All participants receive one telephone intervention or the other (IE or LHT); due to this, randomization occurs after the first telephone session is already scheduled so as not to waste randomization slots on couples who have no intention of following through with sessions. As such, participants may be lost prior to randomization if they complete consent/baseline but never schedule their first telephone session.

Participants by arm

Arm	Count
Patient Intimacy Enhancement Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.	61
Patient Living Healthy Together Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.	59
Partner Intimacy Enhancement Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.	61
Partner Living Healthy Together Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.	59
Total	240

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	3	10

Baseline characteristics

Characteristic	Patient Living Healthy Together	Total	Partner Living Healthy Together	Partner Intimacy Enhancement	Patient Intimacy Enhancement
Age, Continuous	51.12 years STANDARD_DEVIATION 9.97	51.60 years STANDARD_DEVIATION 10.26	52.64 years STANDARD_DEVIATION 11.15	52.26 years STANDARD_DEVIATION 10.37	50.39 years STANDARD_DEVIATION 9.6
Education College degree	18 Participants	78 Participants	21 Participants	16 Participants	23 Participants
Education Graduate school	21 Participants	64 Participants	13 Participants	17 Participants	13 Participants
Education High school	8 Participants	38 Participants	11 Participants	13 Participants	6 Participants
Education Less than high school	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Education Some college	12 Participants	58 Participants	13 Participants	14 Participants	19 Participants
Employment Employed full time/part time	43 Participants	178 Participants	45 Participants	48 Participants	42 Participants
Employment Retired	4 Participants	25 Participants	9 Participants	8 Participants	4 Participants
Employment Unemployed/on disability	12 Participants	37 Participants	5 Participants	5 Participants	15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants	235 Participants	58 Participants	60 Participants	60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Length of Relationship (years)	20.54 years STANDARD_DEVIATION 12.29	21.10 years STANDARD_DEVIATION 11.94	—	—	21.65 years STANDARD_DEVIATION 11.66
Level of Sexual Concerns	6.32 units on a scale STANDARD_DEVIATION 1.99	6.25 units on a scale STANDARD_DEVIATION 1.94	—	—	6.18 units on a scale STANDARD_DEVIATION 1.9
Patient Chemotherapy Received Chemotherapy not received	28 Participants	49 Participants	—	—	21 Participants
Patient Chemotherapy Received Chemotherapy received	31 Participants	71 Participants	—	—	40 Participants
Patient Clinical Tumor Stage cT1	36 Participants	75 Participants	—	—	39 Participants
Patient Clinical Tumor Stage cT2	15 Participants	31 Participants	—	—	16 Participants
Patient Clinical Tumor Stage cT3	6 Participants	10 Participants	—	—	4 Participants
Patient Clinical Tumor Stage cT4	2 Participants	4 Participants	—	—	2 Participants
Patient Currently Receiving Endocrine/Ovarian Suppression Therapy Currently receiving endocrine/ovarian suppression therapy	43 Participants	88 Participants	—	—	45 Participants
Patient Currently Receiving Endocrine/Ovarian Suppression Therapy Not currently receiving endocrine/ovarian suppression therapy	16 Participants	32 Participants	—	—	16 Participants
Patient Endocrine Therapy Received Endocrine therapy not received	11 Participants	28 Participants	—	—	17 Participants
Patient Endocrine Therapy Received Endocrine therapy received	48 Participants	92 Participants	—	—	44 Participants
Patient Gynecologic Surgeries Hysterectomy	9 Participants	24 Participants	—	—	15 Participants
Patient Gynecologic Surgeries No gynecologic surgery	39 Participants	67 Participants	—	—	28 Participants
Patient Gynecologic Surgeries Oophorectomy	11 Participants	29 Participants	—	—	18 Participants
Patient Immunotherapy Received Immunotherapy not received	47 Participants	95 Participants	—	—	48 Participants
Patient Immunotherapy Received Immunotherapy received	12 Participants	25 Participants	—	—	13 Participants
Patient Menopausal Status Peri-menopausal	9 Participants	11 Participants	—	—	2 Participants
Patient Menopausal Status Post-menopausal	34 Participants	80 Participants	—	—	46 Participants
Patient Menopausal Status Pre-menopausal	16 Participants	29 Participants	—	—	13 Participants
Patient Ovarian Suppression therapy Received Ovarian suppression not received	48 Participants	95 Participants	—	—	47 Participants
Patient Ovarian Suppression therapy Received Ovarian suppression received	11 Participants	25 Participants	—	—	14 Participants
Patient Radiotherapy Received Radiotherapy not received	14 Participants	27 Participants	—	—	13 Participants
Patient Radiotherapy Received Radiotherapy received	45 Participants	93 Participants	—	—	48 Participants
Patient Surgery Received Lumpectomy	25 Participants	49 Participants	—	—	24 Participants
Patient Surgery Received Mastectomy without reconstruction	12 Participants	25 Participants	—	—	13 Participants
Patient Surgery Received Mastectomy with reconstruction	22 Participants	46 Participants	—	—	24 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	7 Participants	31 Participants	8 Participants	8 Participants	8 Participants
Race (NIH/OMB) More than one race	2 Participants	4 Participants	2 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	48 Participants	201 Participants	48 Participants	53 Participants	52 Participants
Region of Enrollment United States	59 participants	240 participants	59 participants	61 participants	61 participants
Relationship Status Cohabitating, not married	9 Participants	11 Participants	—	—	2 Participants
Relationship Status Married	49 Participants	107 Participants	—	—	58 Participants
Sex: Female, Male Female	59 Participants	123 Participants	3 Participants	0 Participants	61 Participants
Sex: Female, Male Male	0 Participants	117 Participants	56 Participants	61 Participants	0 Participants
Sexual Orientation Bisexual	1 Participants	6 Participants	3 Participants	0 Participants	2 Participants
Sexual Orientation Heterosexual/straight	56 Participants	231 Participants	55 Participants	61 Participants	59 Participants
Sexual Orientation Homosexual/lesbian/gay	2 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Time Since Diagnosis (months)	31.32 months STANDARD_DEVIATION 13.02	29.98 months STANDARD_DEVIATION 13.94	—	—	28.69 months STANDARD_DEVIATION 14.77
Time Since Treatment Completion (months)	23.55 months STANDARD_DEVIATION 12.52	21.95 months STANDARD_DEVIATION 12.83	—	—	20.40 months STANDARD_DEVIATION 13.04

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 61	0 / 59	0 / 61	0 / 59
other Total, other adverse events	3 / 61	6 / 59	2 / 61	4 / 59
serious Total, serious adverse events	0 / 61	0 / 59	0 / 61	0 / 59

Outcome results

Primary

Change in Self-Reported Patient Sexual Function

Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.