Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention
Condition: Cancer
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 2

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. 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.
    

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.
    

Intervention name(s): Exercise Behaviour Maintenance; Smoking Relapse prevention booklets; Contact control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.; 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).
Other intervention name(s): Physical Activity; Educational material, relapse prevention, Forever Free; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: smoking cessation; exercise maintenance; preventing relapse; weight gain; group-mediated cognitive behavioural therapy