IMPRESS: predictors of daily life resilience in advanced cancer patients

Completed

Conditions: distress symptoms
Psychological distress
10037173

Registration Number: NL-OMON54145

Lead Sponsor: niversiteit van Tilburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

- diagnosed with stage IV melanoma with confirmed response to or long-term
stable disease while on immunotherapy;
- or stage IV lung cancer with confirmed response to or long-term stable
disease while on immunotherapy or targeted therapy.

We consider a response confirmed after the second scan shows that patients
respond well (i.e. RECIST at least partial response or >1 year of stable
disease) to one of both therapies.

Exclusion Criteria

- <18 years of age;
- not able to sufficiently use and understand the Dutch language;
- have no smartphone or internet access.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A week before participants start with ESM, they will complete several baseline<br /><br>questionnaires. During a two-week period participants are asked to complete ESM<br /><br>eight times per day via an app on their phone. Positive affect, negative<br /><br>affect, daily life events, predictors (i.e. fatigue, pain, emotion regulation<br /><br>and coping), and contextual predictors (i.e. location and company) will be<br /><br>measured in these ESM items. Analyses will be conducted separately for two<br /><br>resilience outcomes (recovery and reward experience). For each model, potential<br /><br>predictors (baseline predictors, momentary predictors, contextual predictors)<br /><br>will be entered as moderators.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective in this study is to explore whether reward response<br /><br>despite adversity (i.e. advanced cancer diagnosis) predicts low psychosocial<br /><br>distress (symptoms of depression and anxiety) and more illness acceptance,<br /><br>tolerance of uncertainty, mindfulness, optimism and perceived social support a<br /><br>year after measuring resilience in daily life. To explore this, participants<br /><br>will complete a follow-up questionnaire approximately a year after completing<br /><br>the ESM items. This questionnaire contains items about psychosocial distress,<br /><br>illness acceptance, tolerance of uncertainty, mindfulness, optimism, and<br /><br>perceived social support.</p><br>