NCT07267936

Brief Summary

This feasibility study evaluates the effectiveness of a household-based smoking cessation intervention for patients and their household members. Patients who smoke and live with household members who also smoke will be invited to participate in the Treating Tobacco Dependency (TTD) program at Royal Papworth Hospital. The study aims to assess whether providing support to both patients and their household members improves quit rates and reduces relapse risk. Participants will receive nicotine replacement therapy (NRT) and behavioural support, with follow-up assessments at 28 days, 3 months, and 12 months after starting the program. This study will compare outcomes to historical data from patients who participated in the TTD program without household support.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Jul 2025Nov 2026

First Submitted

Initial submission to the registry

May 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

May 22, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Household-based interventionSmoking CessationTobacco dependency

Outcome Measures

Primary Outcomes (1)

  • Quit Rate among patients at 28 days

    Assess difference in quit rates between patients with household support and the control group at 28 days.

    28 days

Secondary Outcomes (4)

  • Patient relapse rate

    3 and 12 months

  • Household member quit rate

    28 days, 3 months and 12 months

  • Difference in relapse rate between patients with and without household members support

    3 months and 12 months

  • Acceptance rate of support among household members

    Baseline (At the time of screening , prior to enrollment)

Study Arms (1)

Patients with household members support

EXPERIMENTAL

Both the patients and the additional household members will be provided with Nicotine Replacement Therapy products and behavioural support. All participants will be followed up at 28 days, 3 months and 12 months post start Quit Date. The intervention in this study involves inviting household members of the patients, to participate in the Treating Tobacco Dependency program. The control group is patients without household members support. This is based on retrospective data of all patients who were admitted to Papworth Hospital and engaged with the Treating Tobacco Dependency Programme without any household members invited.

Other: Household member support

Interventions

The intervention in this study involves inviting household members of the patients, to participate in the Treating Tobacco Dependency program.

Patients with household members support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any inpatient aged 18 and above admitted to Papworth Hospital who smoke. (Smoking is described as using any tobacco products as defined by the TTD programme)
  • Patient and household members must be eligible to join the TTD programme.
  • Patients must live in a household with other smokers.
  • Participants must live in Cambridgeshire and/or be registered with a GP Practice in the Cambridgeshire \& Peterborough Integrated Care System

You may not qualify if:

  • Pregnant individuals - Pregnant individuals who smoke are offered a differing pathway to the standard TTD programme.
  • Contraindications for NRT.
  • Any household member who smokes unwilling to participate.
  • Individuals already enrolled on smoking cessation programme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Health Inequalities Specialist

    Royal Papworth Hospital NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Clinical Project Manager

CONTACT

Papworth Treating Tobacco Dependency Team

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The intervention in this study involves inviting household members of the patients, to participate in the TTD program.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

December 5, 2025

Study Start

July 7, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations