4. Methods of included studies
4.1. Study designs
4.1.1. Study 1: Pilot study with qualitative focus group interviews (paper I)
In study 1, a multidisciplinary residential rehabilitation programme with a primary focus on the physical, psychological and social aspects of eating problems after treatment for HNC (hereinafter referred to as the
“NUTRI-HAB programme”) was pilot tested, and qualitative focus group interviews were carried out with participants.
In 2013 and 2014, RcDallund had offered the NUTRI-HAB programme twice with a maximum of 19 participants in each programme. The NUTRI-HAB programme was based on RcDallund’s core model for residential rehabilitation programmes and adjusted through available evidence to meet the specific
rehabilitation needs of HNC survivors. Due to the complexity of HNC survivors’ rehabilitation needs, the programme was delivered as a coordinated multidisciplinary effort. The programme consisted of five days initial residential stay with two days follow-up residential stay after three months. In 2018, the NUTRI-HAB programme was offered once at REHPA with a maximum of 20 participants.
At RcDallund, different foods and drinks were used as stimulus materials in focus group interviews. With inspiration from participant-driven photo elicitation119, participants at REHPA were encouraged to bring pictures of situations (own photos or pictures from websites, magazines etc.) where eating problems affected their everyday life. With participants’ permission, these pictures were used as stimulus materials6.
Participants in the NUTRI-HAB programme at REHPA were furthermore asked to complete selected nutrition screening tools, and their experiences of the tools regarding content relevance and user-friendliness were explored in the focus group interviews.
4.1.2. Study 2: Nationwide cross-sectional survey (paper II)
In study 2, a nationwide cross-sectional survey was carried out, and all Danish HNC survivors who had completed curatively intended radiation therapy for pharyngeal, laryngeal, or oral cancer 1-5 years before survey distribution were invited to participate120. The survey population was identified through the Danish Head and Neck Cancer Group’s (DAHANCA) national clinical quality database. All hospital departments treating HNC are obliged to register patients in the database, and data can be obtained for research
purposes upon application121. Updated contact information and permission to contact the population was obtained upon application to The Danish Health Data Authority.
CHAPTER 4. METHODS OF INCLUDED STUDIES
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The scope of the survey was broader than the objectives defined in study 2, and the 145-item survey questionnaire was composed of different validated questionnaires, items from other pre-tested questionnaires, and few purpose-designed items (Table 6).
Table 6: Content of the questionnaire used in the nationwide cross-sectional survey in study 2
Domain Questionnaire/origin of items Number
of items
Demographics Current cancer status Purpose-designed items 2
Civil status and living arrangements REHPA core questionnaire122 1
Health behaviour Alcohol consumption REHPA core questionnaire122 2
Smoking REHPA core questionnaire122 3
Physical activity The Danish National Health Survey (2013)123 2
REHPA core questionnaire122 3
Nutritional status, nutritional risk and presence of
nutrition impact symptoms
Nutritional risk or deficit. PG-SGA SF110 4
Purpose-designed items based on NRS 2002107 2 Dysphagia-specific QOL MDADI113 (Danish version includes 4 extra
items117)
24 Pre-cancer weight, weight loss, use of
oral nutritional supplements/enteral nutrition.
Purpose-designed items 4
Perception of own body weight The Danish National Health Survey (2017)124 1 Health-related QOL Generic health-related QOL EuroQol EQ-5D-5L125 6
Cancer-specific QOL EORTC QLQ-C30126,127 30
HNC-specific QOL EORTC QLQ-H&N35127,128 35
Psychological wellbeing
Symptoms of anxiety and depression HADS129 14
Rehabilitation Rehabilitation needs REHPA scale (adapted from the National Comprehensive Cancer Network® Distress Thermometer130)
1
Offered rehabilitation services and participation in these
Items from REHPA core questionnaire122 adapted to HNC
2 Experiences and perceptions of offered
rehabilitation services
Purpose-designed items 3
Relatives Perceived support from relatives The Danish Cancer Society’s barometer survey 2013104
1 Perceived level of support for relatives
from the health system
The Danish Cancer Society’s barometer survey 2013104
3 NUTRI-HAB
programme
Interest in participating in the
NUTRI-HAB programme and in study 3
Purpose-designed item 1
Request for permission to contact the individual with further information
Purpose-designed item 1
EORTC: The European Organization for Research and Treatment of Cancer, HADS: Hospital Anxiety and Depression Scale, HNC: Head and neck cancer, MDADI: M. D. Anderson Dysphagia Inventory, NRS 2002: Nutritional Risk Screening 2002, PG-SGA SF: Scored Patient-Generated Subjective Global Assessment Short Form, QOL: Quality of life.
CHAPTER 4. METHODS OF INCLUDED STUDIES
25
4.1.3. Study 3: Randomised controlled trial (paper III and paper IV)
Study 3, the NUTRI-HAB trial, was a randomised controlled trial qualified by the results from the previous two studies. In the trial, effects of the NUTRI-HAB programme compared to standard care on body weight, QOL and physical function were tested.
Participants recruited among participants from study 2 were randomised to participation in the NUTRI-HAB programme at REHPA from baseline to 3-months follow-up or to a wait-list control group, that participated in the NUTRI-HAB programme from 3-months to 6-months follow-up (Figure 4). Groups were compared at 3-month follow-up to assess intervention effect131.
Intervention group
BASELINE MEASUREMENTS
5 days residential rehabilitation
programme
2 telephone consultations with
clinical dietitian
OUTCOME MEASUREMENTS
2 days follow-up residential
stay
Standard care
6-MONTH MEASUREMENTS
Wait-list control group
5 days
residential rehabilitation
programme
2 telephone consultations with
clinical dietitian
2 days follow-up residential
stay Standard care
TIME
(MONTHS)
Figure 4: Timeline of the NUTRI-HAB trial
In study 1, the mean body weight change in percent during participation in the NUTRI-HAB
programme was 1.74±2.37 when restricting to participants with cancer of the pharynx, larynx, or oral cavity who were 1-5 years posttreatment. Hence, to detect this difference between groups with a power of 80% and a significance level of 5%, 30 participants were required in each group in study 3.
With an estimated withdrawal rate of 15%6, the aim was to include 36 participants in each group131. 3 6
0
Collected data from baseline to 6-month follow-up will be used for exploratory data analyses.
Developments in primary and secondary outcomes will be used to test for differences between groups.
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