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Trauma-informed interventions for cancer-risk behaviours among adults

A randomised controlled trial of trauma-informed interventions versus control for cancer-risk behaviours among adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15583681
Enrollment
300
Registered
2019-08-21
Start date
2019-03-11
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-risk behaviours Not Applicable Problems related to lifestyle

Interventions

Participants will engage in one of four conditions. Each intervention session and each pre and post-intervention assessment will take approximately 90 minutes. All spaces selected for interventions ar

Sponsors

Faculty of Health Sciences, University of Lethbridge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 10/07/2020: 1. 18 years and older 2. Currently live at a permanent residential address in Lethbridge, AB 3. Plan to live in Lethbridge for the next 12 months 4. Smoked, consumed alcohol, or consumed sugar-sweetened beverages at least once in the past month Previous inclusion criteria: 1. Identify as First Nations, Métis, Inuit or Indigenous 2. 18 years and older 3. Currently live at a permanent residential address in Lethbridge, AB 4. Plan to live in Lethbridge for the next 12 months 5. Smoke (any amount), consume 4 or more drinks at least once in past month, or consumed sugar-sweetened beverages at least once in the past week. 6. Experienced a psychologically traumatizing event in their lives

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
1. Smoking is measured using 4 items and salivary cotinine concentration at baseline, 1-month follow-up and 6-month follow-up. 2. Hazardous alcohol use is measured using AUDIT at baseline, 1-month follow-up and 6-month follow-up. 3. Sugar-sweetened beverage consumption is measured using 3 items at baseline, 1-month follow-up and 6-month follow-up.

Secondary

MeasureTime frame
Psychological stress symptomology 1. PTSD is measured using PTSD Checklist at baseline, 1-month follow-up and 6-month follow-up. 2. Dissociative experiences is measured using BDE-S at baseline, 1-month follow-up and 6-month follow-up. 3. Depression is measured using 2 items at baseline, 1-month follow-up and 6-month follow-up. 4. Suicide is measured using 2 items at baseline, 1-month follow-up and 6-month follow-up. 5. Complicated grief is measured using BGQ at baseline, 1-month follow-up and 6-month follow-up. 6. Self-esteem is measured using RSES at baseline, 1-month follow-up and 6-month follow-up. 7. Self-compassion is measured using SCS-SF at baseline, 1-month follow-up and 6-month follow-up. 8. Resilience is measured using CD- at baseline, 1-month follow-up and 6-month follow-up. Physiologic stress symptomology 1. Neuroendocrine is measured using Salivary DHEA-S at baseline, 1-month follow-up and 6-month follow-up. 2. Metabolic is measured using BMI, waist circumference at baseline, 1-month follow-up and 6-month follow-up. 3. Cardiovascular is measured using Blood pressure, heart rate, uric acid at baseline, 1-month follow-up and 6-month follow-up. 4. Immune is measured using Secretory IgA, CRP, Interleukins IL-1ß, IL-6, IL-8, TNF-a at baseline, 1-month follow-up and 6-month follow-up. 5. General health is measured using 14 items at 1-month follow-up and 6-month follow-up. Social dislocation 1. Social Support is measured using SSQ at baseline, 1-month follow-up and 6-month follow-up. 2. Social Support is measured using VI at baseline, 1-month follow-up and 6-month follow-up. Coping behaviour 1. Physical activity is measured using IPAQ at baseline, 1-month fol

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026