Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff.

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.

Reach Plus

Reach Plus Phone

Reach Plus Message

Bernardine M Pinto, PhD

Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained American Cancer Society volunteers to provide exercise counseling to breast cancer survivors and the survivors increased their exercise in the short-term. This RCT examines the effects of three maintenance conditions on survivors' exercise participation at longer follow-ups. The cost-effectiveness of the three groups will be examined to guide implementation of this peer mentoring approach in community-based organizations.

The current study, a randomized controlled trial (RCT), represents the next step of the efforts to to extend the research on physical activity to the community setting; community volunteers will deliver the intervention, thereby making physical activity interventions much more accessible to survivors. In partnership with the National American Cancer Society office (Atlanta, GA) and Reach To Recovery (RTR) programs in North Carolina, South Carolina, and Georgia, researchers at the University of South Carolina's College of Nursing will share skills, experience and resources to examine the effects of RTR coaches offering a theoretically-based 3-month exercise program among 150 breast cancer survivors to increase moderate-to-vigorous physical activity (MVPA) followed by self-monitoring (i.e. exercise logs) and feedback reports in Months 4-9 (Reach Plus), monthly phone calls from RTR coaches, self monitoring and feedback reports in Months 4-9 (Reach Plus Message) or weekly email/text messages, self-monitoring and feedback reports in Months 4-9 (Reach Plus Message). In this three group study, researchers will assess survivors' exercise, fatigue, mood, quality of life, and self-reported physical functioning at baseline, 3, 9 and 12 months. The costs of the methods vary and data on costs will be collected to guide the selection of maintenance strategies for dissemination. If the results are promising, researchers will proceed with a dissemination trial wherein the large network of RTR volunteers can expand the scope of their services to benefit breast cancer survivors.

Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

Through interviewer - administered Seven Day Activity Recall \& wearing the Actigraph accelerometer (GT3X)

Assessed via the Functional Assessment of Cancer Therapy Scale - Breast (FACT-B) Sub-scales scored: Physical well-being, social/family well-being, emotional well-being, functional well-being and other breast cancer related statements.

Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F)

Assessed via the Profile of Mood States (POMS)

American Cancer Society, Inc.

University of South Carolina

Associate Dean

Symptoms and General Pathology

Body Weight

Weight Gain

Recurrence

Disease Attributes

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Randomization and Group-Mediated Cognitive Behavioural therapy (GMCB) sessions will begin on week 8 of the program. Topics of self-regulation related to exercise (Social cognitive theory of self-regulation, Albert Bandura, 1991) will be discussed: monitoring, scheduling, goal setting, coping, overcoming barriers, rewards, social support.

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) intervention strategies over the phone to continue to enhance the GMCB principles on how to maintain exercise behavior.

The same topics of self-regulation related to exercise maintenance(Social cognitive theory of self-regulation, Albert Bandura, 1991) will be discussed: monitoring, scheduling, goal setting, coping, overcoming barriers, rewards, social support.

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) intervention strategies over the phone to continue to enhance the Group-Mediated Cognitive Behavioural therapy (GMCB) principles on how to maintain exercise behavior.

Participants in this arm will also receive the Brandon et al. (2004) Forever Free smoking relapse prevention booklets.

Randomization and group discussion sessions will begin on week 8 of the program. Topics of women's health, unrelated to exercise will be discussed (control).

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to continue to maintain contact time.

Participants in this arm will also receive the Brandon et al. (2004) Forever Free smoking relapse prevention booklets.

Randomization and group discussion sessions will begin on week 8 of the program. Topics of women's health, unrelated to exercise will be discussed (control).

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to continue to maintain contact time.

Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to remind the participants of the self-regulatory skills they learned during group discussion.

Exercise Behaviour Maintenance

Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.

Smoking Relapse prevention booklets

No treatment, but equal contact time as the other intervention arms. Topics of women's health, unrelated to exercise will be discussed in group-mediated sessions(control).

Contact control

Harry Prapavessis, Ph.D.

Adult female smokers will participate in an exercise-aided smoking cessation program, and will then be randomized into one of four cessation maintenance conditions: (a) Exercise Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse Prevention Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking behaviour. Secondary outcomes include exercise behaviour, Physiological measures (body composition (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness, endothelial function, carotid plaque volume), physical fitness), and Psychological measures (self-regulatory cognitions related to exercise adherence \[exercise, scheduling, barrier, relapse, and concurrent self-regulatory self-efficacy\]).

The hypotheses detailed below are specific to the randomization of participants into the following 4 groups:

1. Exercise Maintenance only
2. Exercise Maintenance + Relapse Prevention Booklets
3. Relapse Prevention Booklets + Contact
4. Contact Control

Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater exercise adherence and fitness levels, as well as significantly less weight gain and smoking relapse rates following exercise-aided smoking cessation program termination.

Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to relapse information only (Relapse Prevention Booklets + Contact) will experience significantly less smoking relapse following exercise-aided smoking cessation program termination.

Due to the novelty and exploratory nature of the respective prevention programs, no hypotheses are specified with respect to which prevention program (exercise maintenance or relapse prevention information) will be superior to the other, or whether the additive benefits (i.e., exercise maintenance plus relapse prevention information) will be superior to one prevention program alone.

Adding exercise to cognitive behaviour therapy (CBT) has been shown to aid smoking cessation and lessen some of the negative consequences of withdrawal symptoms (Marcus et al., 1999; Ussher, 2005). Recently, Prapavessis and colleagues (2007) demonstrated that their 12-week program, consisting of supervised vigorous intensity exercise as an adjunct to nicotine replacement therapy (NRT), facilitates smoking cessation, improves physical fitness, and delays weight gain in women smokers. However, a smoking relapse effect was shown post-intervention, illustrating a trend where, as abstinence decreased, physical fitness showed a corresponding decrease and an increase in weight (also see, Marcus et al.). These results suggest that exercise needs to be maintained if it is to be an effective aid to smoking cessation.

In practice, long-term supervised and structured vigorous exercise regimes are beyond the scope of smoking cessation services. Therefore, it is important to determine whether an exercise intervention program can be developed to maintain weight and physical fitness after program termination, and thus prevent (or reduce) smoking relapse. Teaching smokers the necessary self-regulatory skills needed to abstain from smoking and adhere to exercise independently may be a promising avenue through which to ensure lasting health behaviour changes.

The Getting Physical on Cigarettes program will begin in January 2010. The main purpose of this project is to examine whether an inexpensive, home-based lifestyle exercise maintenance intervention can demonstrate sustained health benefits in terms of weight gain and physical fitness benefits following an exercise and Nicotine Replacement Therapy (NRT) aided smoking cessation program. In addition, this trial seeks to examine previously unexplored topics of interest in the smoking abstinence literature; specifically, we are interested in whether the nicotine metabolite ratio (3-HC/Cotinine: Schnoll et al., 2009) is a useful biomarker for determining cessation success in relation to exercise and Nicotine Replacement Therapy (NRT) treatment, and whether the interactive effects of exercise and smoking cessation improve vascular health and lung function.

Four hundred and twenty adult female smokers will follow a structured and supervised 14 week exercise-aided smoking cessation program, with the 10 week NRT program beginning at week 4. Participants will be randomized into one of four conditions: a) Exercise Maintenance; b) Exercise Maintenance + Relapse Prevention Booklets; c) Relapse Prevention Booklets + Contact; and d) Contact Control. Starting at week 8, women in the Exercise Maintenance conditions will engage in Group-Mediated Cognitive Behavioural (GMCB) therapy related to maintaining exercise in their home environment, while women in the Contact conditions will partake in group mediated discussions related to other health issues. The "Forever Free" smoking replase prevention book series (Brandon, Collins, Juliano, \& Lazev, 2000) will be distributed to participants in the Relapse Prevention Booklets conditions; however, all groups will receive the same amount of supervised exercise sessions and NRT. Following the termination of the 14 week intervention all participants will be contacted by a trained facilitator, who will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) intervention strategies over the phone to continue to counsel the women according to her particular group-mediated condition.

Primary end points (i.e., smoking abstinence) will be assessed weekly throughout the 14 week program and through follow-ups at 3, 6, and 12 months. Secondary end points (i.e., fitness, vascular health \[e.g., endothelial function, carotid plaque volume\], lung function, weight and self-regulatory cognitions) will be assessed at baseline and at week 14 as well as at 12 months. Accelerometers (ACTICALÒ) will be used to obtain an objective measure of physical activity at baseline, week 15 (1 week after the 14 week intervention) and at 6 and 12 months.

The Getting Physical on Cigarettes trial will not only contribute to a better understanding of the role exercise plays as an aid to smoking cessation, but will also explore a means of increasing the cost-effectiveness of long-term smoking cessation programs. The findings resulting from this trial may have important implications for improving the quality of life among individuals who wish to stop smoking, which would, in turn, have a significant impact on the cost of health care to the Canadian public.

Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention

Getting Physical on Cigarettes: Exercise and Smoking Cessation - Preventing Relapse

Continuous smoking behaviour will be measured from week 4-week 14, week26, week 56 (one year following quit). Smoking behaviour will be measured via self-report, breath Carbon Monoxide less than 6 parts per million, saliva cotinine.

Exercise behaviour will be measured via Actical accelerometer at baseline, week 14, week 26 and week 56.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors	NCT02694640	Breast Cancer	Reach Plus Reach Plus Phon... Reach Plus Mess...	21 Years -	University of South Carolina
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors	NCT02694640	Breast Cancer	Reach Plus Reach Plus Phon... Reach Plus Mess...	21 Years -	University of South Carolina
Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention	NCT01305447	Cancer	Exercise Behavi... Smoking Relapse... Contact control	18 Years - 65 Years	University of Western Ontario, Canada

Spots Global Cancer Trial Database for exercise maintenance