Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Anxiety Disorders

Depression

Depressive Disorder

Fatigue

Mental Disorders

Psychotic Disorders

Patients and caregivers receive standard of care.

Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.

Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.

educational intervention

CAM exercise therapy

Watch mindfulness exercise video and/or educational video

caregiver-related intervention or procedure

questionnaire administration

laboratory biomarker analysis

Jane Figueiredo

This randomized pilot trial studies mindfulness-based program in educating patients with colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce stress and fatigue in patients with colorectal cancer and their caregivers.

PRIMARY OBJECTIVES:

I. To evaluate the effect of a brief educational program on colorectal cancer knowledge acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing visual/written educational material with and without mindfulness training to the standard of care.

II. To determine the priming effect of a brief mindfulness training on retaining knowledge of colorectal cancer education.

III. To determine the joint effect of colorectal cancer education delivered to both the patient and a caregiver on the overall colorectal cancer knowledge.

SECONDARY OBJECTIVES:

I. To examine the relative changes in psychobiological variables (stress, anxiety, depression, mindfulness, fatigue, life benefit) from pre (T0) to post (T1) intervention in the 3 arms of the clinical trials.

II. To measure changes in salivary cortisol levels as an indicator of acute stress reactivity across 4 time points across a one-hour period (i.e., 0 min, 20 min, 40 min, 60 min) during active chemotherapy (T1).

III. To determine the moderating effect of baseline peripheral levels of inflammation (interleukin-1 \[IL-1\], IL-6, c-reactive protein \[CRP\] and tumor necrosis factor alpha \[TNFa\]) on the trajectory of salivary cortisol reactivity.

OUTLINE: Patients and caregivers are randomized to 1 of 3 groups.

GROUP I: Patients and caregivers receive standard of care.

GROUP II: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.

GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.

Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers

A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers

The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way analyses of variance (ANOVAs).

The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way ANOVAs.

Cortisol slopes will be calculated with two distinct areas under the curve analyses using the trapezoid formula as outlined by Pruessner 2003. Data values will be entered into a two factor (group by time) multilevel MIXED linear regression model to calculate differences between the three groups. A Scheffe post hoc test will be employed to determine the direction of the differences between the groups.

National Cancer Institute (NCI)

University of Southern California

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Body Weight

Body Weight Changes

Weight Gain

Breast Diseases

Skin Diseases

Behavioral Symptoms

exercise intervention

management of therapy complications

psychosocial assessment and care

quality-of-life assessment

Penny Anderson, MD

RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer.

PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy.

OBJECTIVES:

Primary

* Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy, hormonal therapy, and/or radiotherapy. (phase I)
* Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy. (phase II)
* Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)

Secondary

* Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy. (phase II)
* Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
* Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy. (phase II)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 intervention arms.

* Arm I (exercise and usual care): Patients receive usual care and are enrolled in an exercise and weight control program at Curves® fitness center. The Curves® program, which begins during the third week of study, uses aerobic activity and resistance training to reduce weight and increase strength and fitness. Patients exercise a minimum of 3 times per week, approximately 30 minutes every time, for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients' physical activity is measured at baseline and at the 3- and 6-month follow-up visits.

Patients also undergo behavior modification counseling with a study nurse to help them overcome the specific barriers to adhering to the recommended exercise routine. Counseling sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after completion of chemotherapy for up to 6 months, starting within 2 weeks after randomization and prior to initiation of the Curves® intervention.

* Arm II (control: usual care alone): Patients receive usual care and general advice on coping with their breast cancer treatment for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients receive no counseling or recommendations concerning emotional and practical barriers encountered during breast cancer treatment.

Dietary information is obtained from patients by telephone during three 24-hour dietary recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits to estimate total energy intake throughout the study. Patients complete questionnaires at baseline and periodically during study assessing demographic characteristics and established breast cancer risk factors, medical history, and health changes. Weight, adiposity as measured by waist circumference, quality of life, and depressive symptomology are assessed at baseline and at the 3- and 6-month follow-up visits.

After completion of the study intervention, patients are followed for up to 6 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers	NCT02057991	Anxiety Disorde... Colon Cancer Depression Fatigue Rectal Cancer	educational int... CAM exercise th... caregiver-relat... questionnaire a... laboratory biom...	18 Years - 65 Years	University of Southern California
Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy	NCT00509626	Breast Cancer Depression Fatigue Psychosocial Ef... Weight Changes	exercise interv... questionnaire a... CAM exercise th... management of t... psychosocial as... quality-of-life...	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for cam exercise therapy