Cardiovascular Disease, Chronic Disease, Diabetes Mellitus, Hypertension, Neoplasm, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
veterans, smoking cessation
Brief summary
The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.
Detailed description
ANTICIPATED IMPACT(S) ON VETERAN'S HEALTHCARE: Veterans with chronic disease who continue to smoke exact a significant burden on the VA health care system. Effective smoking cessation programs, that target veterans who continue to smoke after the diagnosis of a smoking-related chronic illness, are needed. BACKGROUND/RATIONALE: Chronic diseases related to tobacco exposure are common among veterans. Persistent tobacco use after being diagnosed with these diseases decreases quality of life and survival. Yet, 30% of veterans with these conditions continue to smoke. Researchers have found that the social environment is important for smokers. In our current NCI-funded study, 70% of veterans with lung cancer identified at least one family member who smokes and 45% live with a family member that smokes. A family-supported smoking cessation intervention timed to follow a veteran's diagnosis of cancer or heart disease could be effective for helping veterans quit smoking. OBJECTIVES: The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients. AIM 1: To evaluate the impact of a family-supported intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 2 weeks, and 12-month post-treatment follow-ups. Hypothesis 1: Abstinence rates will be significantly higher among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control. AIM 2: To evaluate the impact of a family-supported intervention on perceived support for quitting 2 weeks and 12-month post-treatment follow-ups. Hypothesis 2: Perceived support for quitting smoking will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control. AIM 3: To measure the impact of a family-supported intervention on quality of life in veterans 2 weeks, and 12-month post-treatment follow-ups. Hypothesis 3: Symptom-related quality of life will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control. METHODS: Proposed is a two-group design in which 470 veterans who smoke will be randomized to receive: STANDARD TELEPHONE COUNSELING control including a letter from a VA physician encouraging the patient to quit smoking, nicotine replacement (if not contraindicated), a self-help cessation kit, and 5 standard telephone counseling calls; or FAMILY-SUPPORTED intervention that includes all components of the control arm plus a Family-supported intervention that includes a support skills booklet and an additional telephone counseling protocol focusing on social support. .
Interventions
BEHAVIORALFamily-supported
Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking
BEHAVIORALStandard Telephone counseling
Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in the Durham VA for ongoing care * Seen at a DVAMC clinic for care of cancer or cardiovascular disease within the previous 3 months * Current smokers and planning to quit smoking in the next 30 days
Exclusion criteria
* Active diagnosis of psychosis documented in medical record * Does not have access to a telephone * Refusal to provide informed consent * Severely impaired hearing or speech
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention | 5 months | self-reported 7-day point prevalent abstinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up | 12-months follow-up | self-reported 7- day point prevalent abstinence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Family-supported smoking cessation
Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking | 235 |
| Arm 2 Standard smoking cessation
Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions | 236 |
| Total | 471 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 4 |
| Overall Study | Lost to Follow-up | 20 | 22 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | Arm 2 | Total | Arm 1 |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 7.7 | 59.2 years STANDARD_DEVIATION 7.9 | 59.1 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 96 Participants | 188 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 121 Participants | 251 Participants | 130 Participants |
| Sex: Female, Male Female | 19 Participants | 40 Participants | 21 Participants |
| Sex: Female, Male Male | 217 Participants | 431 Participants | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 235 | 0 / 236 |
| serious Total, serious adverse events | 7 / 235 | 13 / 236 |
Outcome results
Primary
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention
self-reported 7-day point prevalent abstinence
Time frame: 5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention | 19.8 percentage of participants that quit |
| Arm 2 | The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention | 22.0 percentage of participants that quit |
Secondary
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up
self-reported 7- day point prevalent abstinence
Time frame: 12-months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up | 22.4 percentage of participants that quit |
| Arm 2 | The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up | 22.4 percentage of participants that quit |