Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer

Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04559854

Acronym

MAC

Enrollment

Registered

2020-09-23

Start date

2019-07-01

Completion date

2020-10-05

Last updated

2025-06-25

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

Conditions

Breast Cancer, Gynecologic Cancer

Brief summary

The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

Detailed description

The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.

Interventions

BEHAVIORALMindful After Cancer

The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of breast or gynecologic cancer at least one year prior to enrollment * Completed primary cancer treatment * English speaking * Have access to a computer, smart phone, or tablet with internet access * Ability to spend 15-30 minutes per day on program activities

Exclusion criteria

\- Stage 0 (carcinoma in situ)

Design outcomes

Primary

Measure	Time frame	Description
Feasibility/ Enrollment in the Study	Baseline (T1)	Percentage of participants enrolled of those eligible
Feasibility/ Retention in the Study	1 month post-intervention (T2)	Number and percentage of participants completing all assessments
Feasibility/ Retention in the Intervention	1 month post-intervention (T2)	Number and percentage attending at least 6 of 8 sessions
Acceptability of the Intervention	1 month post-intervention (T2)	Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.

Secondary

Measure	Time frame	Description
Change From Baseline Body Appreciation at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.
Change From Baseline Anxiety at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.
Change From Baseline Depression at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms
Change From Baseline Interest in Sexual Activity at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity.
Change From Baseline Self-compassion at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Self-Compassion Scale short form. 12 items. Total score is calculated based on mean of item responses (each item ranges 1-5). Higher mean score indicates greater self-compassion.
Change From Baseline Relationship Quality at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality
Change in Facets of Baseline Mindfulness at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness.
Change From Baseline Satisfaction With Sex Life at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction.
Change From Baseline Self-efficacy at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.
Change From Baseline Body Image at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Mindful After Cancer Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. Mindful After Cancer: The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.	22
Total	22

Arm

Count

Mindful After Cancer

Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. Mindful After Cancer: The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.

Total

Baseline characteristics

Characteristic	Mindful After Cancer
Age at Cancer Diagnosis	47.0 years STANDARD_DEVIATION 8.1
Age, Continuous	53.2 years STANDARD_DEVIATION 9.4
Cancer Type Breast	21 Participants
Cancer Type Ovarian	1 Participants
Current Contraception Use	2 Participants
Education College graduate	20 Participants
Education Did not graduate from college	2 Participants
Employment Status Employed	15 Participants
Employment Status Unemployed	7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Has Biological Child(ren)	15 Participants
Health Insurance Coverage No	0 Participants
Health Insurance Coverage Yes	22 Participants
Income < $50,000 annual income	8 Participants
Income > $50,000 annual income	14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	20 Participants
Region of Enrollment United States	22 Participants
Relationship status Not Partnered	7 Participants
Relationship status Partnered	15 Participants
Self-Reported Cancer Stage I	12 Participants
Self-Reported Cancer Stage II	5 Participants
Self-Reported Cancer Stage III	3 Participants
Self-Reported Cancer Stage IV	1 Participants
Self-Reported Cancer Stage Unknown	1 Participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	0 Participants
Sexually Active	13 Participants
Sexual Orientation Bisexual	4 Participants
Sexual Orientation Heterosexual	18 Participants
Time Since Cancer Diagnosis	6.0 years STANDARD_DEVIATION 5.9

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 22
other Total, other adverse events	0 / 22
serious Total, serious adverse events	0 / 22

Outcome results

Primary

Acceptability of the Intervention

Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.

Time frame: 1 month post-intervention (T2)

Arm	Measure	Value (MEAN)	Dispersion
Mindful After Cancer	Acceptability of the Intervention	75.5 score on a scale	Standard Deviation 22.9

Primary

Feasibility/ Enrollment in the Study

Percentage of participants enrolled of those eligible

Time frame: Baseline (T1)

Arm	Measure	Value (NUMBER)
Mindful After Cancer	Feasibility/ Enrollment in the Study	78.6 Percentage enrolled of eligible

Primary

Feasibility/ Retention in the Intervention

Number and percentage attending at least 6 of 8 sessions

Time frame: 1 month post-intervention (T2)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Mindful After Cancer	Feasibility/ Retention in the Intervention	18 Participants

Primary

Feasibility/ Retention in the Study

Number and percentage of participants completing all assessments

Time frame: 1 month post-intervention (T2)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Mindful After Cancer	Feasibility/ Retention in the Study	22 Participants

Secondary

Change From Baseline Anxiety at 1 Month

PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.