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CancerPhase 2NCT01305447

Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention

A Phase 2 study testing Exercise Behaviour Maintenance and Smoking Relapse prevention booklets in people with Cancer, run by University of Western Ontario, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Cancer
What is being tested?
Exercise Behaviour Maintenance and Smoking Relapse prevention booklets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
1 siteCanada
Study dates
Oct 2009to Apr 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Contraindication to regular exercise (e.g., disability, unstable angina)
  • Contraindications to using nicotine replacement therapy (NRT)
  • Currently exercise more than twice a week for 30 or more minutes each bout at a moderate to vigorous intensity level and have done so for the past 6 months
  • On medication for physical and/or mental health reasons that would make compliance with the study protocol difficult or dangerous
  • Have substance dependency problems (e.g., alcohol)
  • Are pregnant or are planning on becoming pregnant during the next year
  • No Medical Doctor approval for exercise or NicoDerm patch (Nicotine Replacement Therapy; NRT)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Exercise and Health Psychology Laboratory - The University of Western Ontario

    London, Ontario, N6A 5B9

Other trials in Canada

About this study

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

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:

Read more
  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.

Read the detailed description

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.

Conditions
Cancer
Being tested
Exercise Behaviour Maintenance, Smoking Relapse prevention booklets, Contact control
Keywords
smoking cessation, exercise maintenance, preventing relapse, weight gain, group-mediated cognitive behavioural therapy
Medical subject headings
Neoplasms, Smoking Cessation, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise Behaviour MaintenanceBehavioural

    Also called Physical Activity

    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.

  • Smoking Relapse prevention bookletsBehavioural

    Also called Educational material, relapse prevention, Forever Free

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

  • Contact controlBehavioural

    Also called Control

    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).

Study groups in NCT01305447
Study groupRoleWhat they receive
Exercise MaintenanceExperimentalRandomization 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.
Receives: Behavioral: Exercise Behaviour Maintenance
Ex. Maintenance + relapse preventionExperimentalThe 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.
Receives: Behavioral: Exercise Behaviour Maintenance; Behavioral: Smoking Relapse prevention booklets
relapse preventionActive comparatorRandomization 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.
Receives: Behavioral: Smoking Relapse prevention booklets
Contact ControlActive comparatorRandomization 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.
Receives: Behavioral: Contact control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking Behaviour

    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.

    Measured: 56 weeks post participant start date

Secondary outcomes (1)
  1. Exercise Behaviour

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

    Measured: for 56 weeks post participant start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01305447
Sponsor's protocol ID
Prapavessis NCIC RCT
Status last verified
Jun 2012
First submitted
25 Feb 2011
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Brandon TH, Collins BN, Juliano LM, Lazev AB. Preventing relapse among former smokers: a comparison of minimal interventions through telephone and mail. J Consult Clin Psychol. 2000 Feb;68(1):103-13. doi: 10.1037//0022-006x.68.1.103.

    PubMed 10710845
  • Brandon TH, Meade CD, Herzog TA, Chirikos TN, Webb MS, Cantor AB. Efficacy and cost-effectiveness of a minimal intervention to prevent smoking relapse: dismantling the effects of amount of content versus contact. J Consult Clin Psychol. 2004 Oct;72(5):797-808. doi: 10.1037/0022-006X.72.5.797.

    PubMed 15482038
  • Marcus BH, Albrecht AE, King TK, Parisi AF, Pinto BM, Roberts M, Niaura RS, Abrams DB. The efficacy of exercise as an aid for smoking cessation in women: a randomized controlled trial. Arch Intern Med. 1999 Jun 14;159(11):1229-34. doi: 10.1001/archinte.159.11.1229.

    PubMed 10371231
  • Prapavessis H, Cameron L, Baldi JC, Robinson S, Borrie K, Harper T, Grove JR. The effects of exercise and nicotine replacement therapy on smoking rates in women. Addict Behav. 2007 Jul;32(7):1416-32. doi: 10.1016/j.addbeh.2006.10.005. Epub 2006 Nov 9.

    PubMed 17097814
  • Schnoll RA, Patterson F, Wileyto EP, Tyndale RF, Benowitz N, Lerman C. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study. Pharmacol Biochem Behav. 2009 Mar;92(1):6-11. doi: 10.1016/j.pbb.2008.10.016. Epub 2008 Oct 31.

    PubMed 19000709
  • Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

    PubMed 34611902
  • Prapavessis H, De Jesus S, Fitzgeorge L, Rollo S. Anthropometric and body composition changes in smokers vs abstainers following an exercise-aided pharmacotherapy smoking cessation trial for women. Addict Behav. 2018 Oct;85:125-130. doi: 10.1016/j.addbeh.2018.06.003. Epub 2018 Jun 7.

    PubMed 29902683

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exercise Behaviour Maintenance and Smoking Relapse prevention booklets in people with Cancer, run by University of Western Ontario, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Behaviour (time frame: 56 weeks post participant start date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01305447, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.

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