Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors

• Sponsor: Jessica Burris (Other)
• Overall Status: Completed
• CT.gov ID: NCT03316170
• Collaborator: Kentucky Lung Cancer Research Program (Other)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation; Social Stress	Behavioral: Social Support; Drug: NRT Sampling	Phase 2

Detailed Description

This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The control group will receive a brief consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs. Additionally, a written directory of a range of social support resources will be delivered to them via mail. The treatment group will receive the aforesaid intervention plus brief advice to quit smoking (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants' perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also important). The emphasis on smoking cessation induction (that is, the inducement or promotion of a quit attempt) is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
• Actual Study Start Date: Nov 6, 2017
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Social Support + NRT Sampling The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.	Behavioral: Social Support; A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.; Drug: NRT Sampling; A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Active Comparator: Social Support The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail,	Behavioral: Social Support; A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.

Outcome Measures

Primary Outcome Measures

1. Accrual Percentage [Day 0 baseline]

   Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100

2. Retention [Through study completion, number of assessments at Day 60 follow-up]

   Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100

3. Acceptability [Day 60 follow-up]

   Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cervical or head/neck cancer diagnosis in the past 5 years

• Resident of rural and/or Appalachian Kentucky county at cancer diagnosis

• Current smoker of ≥ 10 cigarettes per day, on average

• Age 18-75 years old

• Able to read, write, and understand English

Exclusion Criteria:

• Unreliable phone access

• Smoking cessation treatment use in past 30 days

• Non-cigarette tobacco use in the past 30 days

• Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months

• Cognitive or psychiatric disorder that would interfere with ability to provide informed consent or answer survey questions reliably *

• Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric disorders would make someone ineligible: bipolar; delusional; dissociative; intellectual developmental; neurocognitive; psychotic; schizophreniform, schizophrenia, and schizoaffective.

• For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months

• For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky Markey Cancer Center	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• Jessica Burris
• Kentucky Lung Cancer Research Program

Investigators

• Principal Investigator: Jessica Burris, Ph.D., University of Kentucky

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 21, 2021

More Information

Publications

• Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.

• Responsible Party: Jessica Burris, Principal Investigator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT03316170
• Other Study ID Numbers: MCC-17-0495-P3K
• First Posted: Oct 20, 2017
• Last Update Posted: Jul 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Social Support + NRT Sampling	Social Support
Arm/Group Description	The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail. Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail. NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.	The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
Period Title: Overall Study
STARTED	24	25
COMPLETED	17	18
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	Social Support + NRT Sampling	Social Support	Total
Arm/Group Description	The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail. Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail. NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.	The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.	Total of all reporting groups
Overall Participants	24	25	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.78 (9.27)	56.00 (10.00)	55.42 (9.58)
Sex: Female, Male (Count of Participants)
Female	14 58.3%	10 40%	24 49%
Male	10 41.7%	15 60%	25 51%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	24 100%	25 100%	49 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 8.3%	2 8%	4 8.2%
White	22 91.7%	23 92%	45 91.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	24 100%	25 100%	49 100%
Distress Thermometer (NCCN) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.21 (2.95)	4.72 (3.45)	4.47 (3.19)

Outcome Measures

1. Primary Outcome

Title	Accrual Percentage
Description	Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Time Frame	Day 0 baseline

Outcome Measure Data

Analysis Population Description

Across all recruitment methods, a total of 551 individuals were contacted about the study; this number is not tied to study arm. Of these 551 individuals, a subset met the eligibility criteria, enrolled in the study, and were then randomized into one of the study arms.

Arm/Group Title	All Individuals Contacted
Arm/Group Description	All individuals who were contacted about the study.
Measure Participants	551
Number [percentage of participants enrolled]	8.9 37.1%

2. Primary Outcome

Title	Retention
Description	Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100
Time Frame	Through study completion, number of assessments at Day 60 follow-up

Outcome Measure Data

Analysis Population Description

Participants enrolled in the study

Arm/Group Title	Social Support + NRT Sampling	Social Support
Arm/Group Description	The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail. Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail. NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.	The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
Measure Participants	24	25
Number [percentage of participant w/ assessments]	70.8	72.0

3. Primary Outcome

Title	Acceptability
Description	Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.
Time Frame	Day 60 follow-up

Outcome Measure Data

Analysis Population Description

Analysis based on participants who completed the Day 60 assessment and provided data for this outcome

Arm/Group Title	Social Support + NRT Sampling	Social Support
Arm/Group Description	The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail. Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail. NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.	The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
Measure Participants	16	17
Mean (Standard Deviation) [score on a scale]	2.84 (1.09)	1.98 (1.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Individuals Contacted, Social Support
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.06
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.86
	Confidence Interval	(2-Sided) 95%; -1.75 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.44
	Estimation Comments

Adverse Events

Time Frame	Approximately 2 months
Arm/Group Title	Social Support + NRT Sampling		Social Support
Arm/Group Description	The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail. Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail. NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.		The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
All Cause Mortality
	Social Support + NRT Sampling		Social Support
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/24 (4.2%)		0/25 (0%)
Serious Adverse Events
	Social Support + NRT Sampling		Social Support
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Social Support + NRT Sampling		Social Support
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/24 (33.3%)		10/25 (40%)
Cardiac disorders
Irregular heartbeat	2/24 (8.3%)		2/25 (8%)
Rapid heartbeat	2/24 (8.3%)		2/25 (8%)
Gastrointestinal disorders
Diarrhea	3/24 (12.5%)		4/25 (16%)
Heartburn	4/24 (16.7%)		7/25 (28%)
Hiccups	0/24 (0%)		3/25 (12%)
Vomiting or nausea	1/24 (4.2%)		8/25 (32%)
General disorders
Burning in throat or mouth	3/24 (12.5%)		5/25 (20%)
Dizziness	5/24 (20.8%)		8/25 (32%)
Dry mouth	6/24 (25%)		7/25 (28%)
Excessive saliva	0/24 (0%)		3/25 (12%)
Insomnia	7/24 (29.2%)		8/25 (32%)
Sore mouth	2/24 (8.3%)		4/25 (16%)
Sore throat	4/24 (16.7%)		3/25 (12%)
Weakness	4/24 (16.7%)		8/25 (32%)
Nervous system disorders
Headache	4/24 (16.7%)		5/25 (20%)
Respiratory, thoracic and mediastinal disorders
Breathing difficulty	6/24 (25%)		5/25 (20%)
Skin and subcutaneous tissue disorders
Skin irritation	2/24 (8.3%)		3/25 (12%)
Skin itchiness	2/24 (8.3%)		5/25 (20%)
Skin redness	2/24 (8.3%)		4/25 (16%)
Skin swelling	1/24 (4.2%)		2/25 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.